A Study to Evaluate the Long-Term Safety and Efficacy of GDC-0853 in Participants With Moderate to Severe Rheumatoid Arthritis Enrolled in Study GA29350

Phase 2

Completed

Conditions: Rheumatoid Arthritis

Interventions: Drug: GDC-0853

Registration Number: NCT02983227

Lead Sponsor: Genentech, Inc.

Brief Summary: A study to evaluate the long-term safety and efficacy of GDC-0853 in participants with moderate to severe active Rheumatoid Arthritis (RA) who have completed 12 weeks of study treatment in Study GA29350. Eligible participants from Study GA29350 who elect to participate will receive treatment with GDC-0853 twice daily (BID) in an open-label fashion for 52 weeks, followed by a safety follow-up period of 8 weeks.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 496

Inclusion Criteria

Completion of treatment as specified in Study GA29350, including completion of the Day 84 study visit assessments
Acceptable safety and tolerability during Study GA29350 as determined by the investigator or Medical Monitor
Have not received any prohibited medications in Study GA29350
While taking methotrexate, must be willing to receive oral folic acid (at least 5 milligrams per week [mg/week])
If receiving oral corticosteroids (less than or equal to [</=] 10 milligrams per day [mg/day] prednisone or equivalent) and/or non-steroidal anti-inflammatory drugs, doses have remained stable for the duration of Study GA29350

Exclusion Criteria

Met protocol defined treatment stopping criteria during Study GA29350
Treatment with any investigational agent (i.e., other than study drug) or live/attenuated vaccine or any other prohibited medication during Study GA29350 or since the last administration of study drug in Study GA29350
In the opinion of the investigator, any new (since initially enrolling in the Phase II Study GA29350), significant, uncontrolled comorbidity that would increase the risk to the participant in Study GA30067
Pregnant or lactating, or intending to become pregnant during the study
Participants who experienced a de novo or reactivated serious viral infection such as hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) during the Phase II Study GA29350
Any major episode of infection requiring hospitalization or treatment with intravenous antibiotics during the Phase II Study GA29350
Participants who developed a malignancy during the Phase II Study GA29350
12-lead electrocardiogram (ECG) on Day 84 in Study GA29350 that demonstrates clinically relevant abnormalities that may affect participant safety or interpretation of study results
Current treatment with medications that are well known to prolong the QT interval

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GDC-0853 (200mg BID) Cohort 1	GDC-0853	Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 1 of Study GA29350. Cohort 1 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to previous methotrexate (MTX) therapy and then randomized to 12 weeks of GDC-0853 (50 mg daily, 150 mg daily, or 200 mg BID), adalimumab, or placebo.
GDC-0853 (200mg BID) Cohort 2	GDC-0853	Participants received GDC-0853 orally twice daily (BID) for 52 weeks, after completing 12 weeks in Cohort 2 of Study GA29350. Cohort 2 participants in GA29350 were enrolled with moderate to severe active Rheumatoid Arthritis (RA) and an inadequate response to one or two tumor necrosis factor (TNF) inhibitors and methotrexate (MTX) therapy, and then randomized to 12 weeks of GDC-0853 (200 mg BID) or placebo.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs)	Day 1 up until 8 weeks after the last dose of study drug (up to 1 year, 2 months)	An Adverse Event (AE) was considered any unfavorable and unintended sign, symptom, or disease associated with the use of the study drug, whether or not considered related to the study drug. Preexisting conditions that worsened during the study were reported as adverse events.
Percentage of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Week 52	Week 52	ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \[either C-reactive protein or Erythrocyte Sedimentation Rate\].

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving ACR50 Response up to Week 12	Weeks 4, 8 and 12	ACR50 response is defined as a ≥ 50% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \[either C-reactive protein or Erythrocyte Sedimentation Rate\].
Percentage of Participants Achieving American College of Rheumatology 20% (ACR20) Response	Weeks 4, 8, 12, 24, 36 and 52	ACR20 response is defined as a ≥ 20% improvement (reduction) compared with baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \[either C-reactive protein or Erythrocyte Sedimentation Rate\]
Percentage of Participants Achieving American College of Rheumatology 70% (ACR70) Response	Weeks 4, 8, 12, 24, 36 and 52	ACR70 response is defined as a ≥ 70% improvement (reduction) compared with Baseline for both total joint count-68 joints (TJC68) and swollen joint count-66 joints (SJC66), as well as for three of the additional five ACR core set variables: Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain; Patient's Global Assessment of Disease Activity and Physician's Global Assessment of Disease Activity over the previous 24 hours using a VAS where left end of the line 0=no disease activity to right end of the line 100=maximum disease activity; Health Assessment Questionnaire: 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do; and acute-phase reactant \[either C-reactive protein or Erythrocyte Sedimentation Rate\].
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (3 Variables) (DAS28-3 CRP)	Baseline, Weeks 4, 8, 12, 24, 36 and 52	The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \< 2.6.
Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (4 Variables) (DAS28-4 CRP)	Baseline, Weeks 4, 8, 12, 24, 36 and 52	The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \< 2.6.
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (3 Variables) (DAS28-3 ESR)	Baseline, Weeks 4, 8, 12, 24, 36 and 52	The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \< 2.6.
Disease Activity Score Based on 28-Joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 ESR)	Baseline, Weeks 4, 8, 12, 24, 36 and 52	The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. DAS28 Remission is defined as a DAS28 score \< 2.6.
Percentage of Participants With Remission Based on Disease Activity Score Based on 28-Joints Count (DAS28)	Weeks 4, 8, 12, 24, 36 and 52	The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control.
Percentage of Participants With Low Disease Activity (LDA) Based on DAS28	Weeks 4, 8, 12, 24, 36 and 52	The DAS28 score is a measure of the patient's disease activity calculated using the tender joint count (TJC) \[28 joints\], swollen joint count (SJC) \[28 joints\], patient's global assessment of disease activity \[visual analog scale: 0=no disease activity to 100=maximum disease activity\] and the erythrocyte sedimentation rate (ESR) for a total possible score of 0 to approximately 10. Scores below 2.6 indicate best disease control and scores above 5.1 indicate worse disease control. LDAS is defined as DAS28 ≤ 3.2
Percentage of Participants With ACR/EULAR Remission	Weeks 4, 8, 12, 24, 36 and 52	Assessed according to the Boolean based definition (tender joint count =\<1, swollen joint count =\<1, C-reactive Protein (CRP) =\<1, and patient global assessment =\<1)
Change From Baseline in Simplified Disease Activity Index (SDAI)	Weeks 4, 8, 12, 24, 36 and 52	Simplified Disease Activity Index (SDAI) is the numerical sum of five outcome parameters: TJC and SJC (based on a 28-joint assessment), PtGA and PhGA (based on 0-10 cm VAS, where 0 = no disease activity and 10 = worst disease activity), and CRP. SDAI total score ranges from 0 (no disease activity) to 86 (maximal disease activity), where higher scores represents higher disease activity. The SDAI =\< 3.3 indicates disease remission, \> 3.4 to 11 indicates low disease activity, \> 11 to 26 indicates moderate disease activity, and \> 26 indicates high disease activity
Change From Baseline in Clinical Disease Activity Index (CDAI)	Weeks 4, 8, 12, 24, 36 and 52	CDAI was derived as the sum of the following: tender joint count (TJC), swollen joint count (SJC), participant global assessment (PGA) of disease activity, and physician assessment of disease activity. TJC and SJC were taken as the number of tender and swollen joints, respectively, out of 28 assessed joints. PGA and physician assessment of disease activity were scored 0-100 millimeters (mm) and rounded to the nearest centimeter (cm) on a visual analog scale (VAS), where higher scores indicate greater perceived disease activity. The total CDAI score range was 0-76, where higher scores indicate increased disease activity. Change from baseline at a particular time point was calculated among patients with data available at both baseline and the time point of interest. Negative values indicate improvement/reduction in RA disease activity.
Change From Baseline in Tender/Painful Joint Count Based on 68 Joints	Weeks 4, 8, 12, 24, 36 and 52	Tender Joint Count: a total of 68 joints will be assessed for tenderness. Each joint is assessed for the presence/absence of tenderness. 68 joints are assessed for tenderness and joints are classified as tender/not tender giving a total possible tender joint count score of 0 to 68. A negative change from Baseline indicated improvement.
Change From Baseline in Swollen Joint Count Based on 66 Joints	Weeks 4, 8, 12, 24, 36 and 52	Swollen Joint Count: a total of 66 joints will be assessed for swelling. Each joint is assessed for the presence/absence of swelling. 66 joints were assessed for swelling and joints are classified as swollen/not swollen giving a total possible swollen joint count score of 0 to 66. A negative change from Baseline indicated improvement.
Change From Baseline in Patient's Assessment of Arthritis Pain, Using Visual Analog Scale (VAS) Score	Weeks 4, 8, 12, 24, 36 and 52	Patient's Assessment of Pain over the previous 24 hours: using a Visual Analog Scale (VAS) left end of the line 0=no pain to right end of the line 100=unbearable pain
Change From Baseline in Patient's Global Assessment of Arthritis, Using VAS Score	Weeks 4, 8, 12, 24, 36 and 52	Participant-assessed arthritis pain was scored on a 100-mm VAS, where the distance from 0 mm represented the participant's self evaluation of arthritis pain (0 mm=none; 100 mm=very severe). Change from baseline at a particular time point was calculated among patients with data available at both baseline and the time point of interest, where negative change indicated a decrease in participant-assessed arthritis pain.
Change From Baseline in Physician's Global Assessment of Arthritis, Using VAS Score	Weeks 4, 8, 12, 24, 36 and 52	Physician's assessment of participant's disease activity was scored on a 100-mm VAS, where the distance from 0 mm represented the physician's assessment of the participant's disease activity (0 mm=very good; 100 mm=very poor). Change from baseline at a particular time point was calculated among patients with data available at both baseline and the time point of interest, where negative change from baseline indicated an improvement in physician-assessed disease activity.
Change From Baseline in C-Reactive Protein (CRP) Levels	Weeks 4, 8, 12, 24, 36 and 52	C-reactive protein is a biological marker of inflammation and is measured in milligrams per decilitre (mg/dL)
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score	Weeks 4, 8, 12, 24, 36 and 52	The Stanford Health Assessment Questionnaire disability index is a patient-reported outcome used to assess difficulty in performing activities of daily living. It consists of 20 questions referring to eight domains: dressing/grooming, arising, eating, walking, hygiene, reach, grip and common daily activities. To respond to each question, a four-level response with higher scores showing larger functional limitations, was chosen. Scoring is as follows with respect to performance of participant's everyday activities: 0 (equals)=without difficulties; 1= with some difficulties; 2=with great difficulties; and 3=unable to perform these actions at all. The composite HAQ-DI score is the mean of the eight domain scores and the score ranges from 0 (no functional impairment) to 3 (maximum functional impairment). A negative change from baseline indicates improvement.
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Version 2.0 (V2) Scores for Physical and Mental Components	Weeks 12, 24 and 52	The 36-Item Short Form Health Survey (SF-36v2) is a questionnaire used to assess functional health and well-being and consists of eight domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health. The SF-36v2 is summarized into Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. The PCS and MCS scores range from 0 to 100, with 0=worst score (or quality of life) and 100=best score. A positive change from baseline indicates improvement.
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score	Weeks 12, 24 and 52	The FACIT-Fatigue Scale consists of 13 items designed to measure the degree of fatigue experienced by the patient in the previous 7 days. For each question, there are five possible responses: 0 (not at all), 1 (a little bit), 2 (somewhat), 3 (quite a bit), 4 (very much). A total fatigue score is calculated by summing all items, and possible total scores range from 0 (maximum fatigue) to 52 (no fatigue). A positive change from baseline indicates an improvement in the patient's fatigue (less fatigue).
Area Under the Concentration Time Curve (AUC) of GDC-0853 at Steady State (AUC,ss)	Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination	Population PK model estimated AUC of GDC-0853 at steady-state. AUC was measured in Nanograms (ng) per millilitre(mL)\*hour (hr).
Minimum Plasma Concentration of GDC-0853 at Steady State (Ctrough,ss)	Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination	Population PK model estimated minimal plasma concentration (Ctrough) of GDC-0853 at steady-state (ss).
Plasma Decay Half-Life of GDC-0853 at Steady State (t1/2,ss)	Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination	Population PK model estimated plasma decay half life of GDC-0853 at steady-state.
Apparent Oral Clearance of GDC-0853 at Steady State (CL/F,ss)	Pre-dose (0 hour) on Weeks 0 (Day 1), 4, 12, 24, 36, and 52/early termination	Population PK model estimated apparent oral clearance of GDC-0853 at steady-state.

Trial Locations

Locations (104): CNI Consultative and Diagnostic Center of Desnianskyi District of Kyiv
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Kyiv, Ukraine
Centrum Medyczne Pratia Katowice I
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Katowice, Poland
CCBR - Lodz - PL
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Lodz, Poland
Consultorio Particular del Dr. Miguel Cortes Hernandez
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Cuernavaca, Mexico
Institute of Treatment and Rehabilitation "Niska Banja"
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Niska Banja, Serbia
Centro de Investigacion Medico Asistencial S.A.S
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Barranquilla, Colombia
Medvin Clinical Research
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Covina, California, United States
TriWest Research Associates, LLC
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El Cajon, California, United States
CIP - Centro Internacional de Pesquisa X; Pesquisa Clinica
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Goiânia, GO, Brazil
Arizona Arthritis & Rheumatology Associates, P.C.
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Glendale, Arizona, United States
CCBR - Buenos Aires - AR; AxisMed SRL
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Ciudad Autonoma Buenos Aires, Argentina
MHAT "Eurohospital" - Plovdiv, OOD; Internal Department
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Plovdiv, Bulgaria
Medizinski Zentrar-1-Sevlievo EOOD
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Sevlievo, Bulgaria
Centro de Investigacion en Enfermedades Reumaticas CIER
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Ciudad Autonoma Buenos Aires, Argentina
CMiP - Centro Mineiro de Pesquisa*X*
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Juiz de Fora, MG, Brazil
ILAIM-CEOM Inst. Latinoamericano de Inv. Medicas
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Cordoba, Argentina
APRILLUS
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Buenos Aires, Argentina
Instituto centenario
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Buenos Aires, Argentina
Instituto de Investigaciones Clinicas
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Rosario, Argentina
Expertia S.A- Mautalen Salud e Investigación
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Ciudad Autonoma Buenos Aires, Argentina
CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica
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San Juan, Argentina
CAEP - Centro Avancado de Estudos e Pesquisas Ltda.
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Campinas, SP, Brazil
DCC "Alexandrovska", EOOD; Clinic of Neurology
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Sofia, Bulgaria
IMA Brasil - Instituto de Medicina Avancada
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Sao Paulo, SP, Brazil
Riesgo de Fractura S.A.
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Bogota, Colombia
Centro de Investigacion en Reumatologia y Especialdades Medicas SAS. CIREEM
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Bogota, Colombia
Centro de Investigacion de Tratam Innovadores de Sin SC
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Culiacan, Mexico
Consultorio Medico en Fundacion el Hospitalito de morelos A.C.
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Cuernavaca, Morelos, Mexico
UMHAT "Kaspela", EOOD
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Plovdiv, Bulgaria
Centro de Investigacion en Reumatologia
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Merida, Yucatan, Mexico
Clinical Research Institute
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Tlalnepantla, Mexico
Unidad de Enfermedades Reumaticas y Cronicodegenerativas
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Torreon, Mexico
Centro de Investigacion Clínica GRAMEL S.C
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Mexico, Mexico
Policlinica Medica de Queretaro S.C.
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Queretaro, Mexico
NZOZ ZDROWIE Osteo-Medic
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Bialystok, Poland
ETYKA Osrodek Badan Kliniczynch
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Olsztyn, Poland
Federal State Budgetary Scientific Institution Research Institute of Rheumatology V.A. Nasonova
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Moscow, Moskovskaja Oblast, Russian Federation
KO-MED Centra Kliniczne Zamosc
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Zamosc, Poland
Sanavita LLC
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Sankt-peterburg, Sankt Petersburg, Russian Federation
SBIH of Yaroslavl region " Regional Clinical Hospital "; Therapy
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Yaroslavl, Jaroslavl, Russian Federation
SBIH of Moscow "City Clinical Hospital # 1 n. a. N. I. Pirogov"
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Moscow, Moskovskaja Oblast, Russian Federation
SPb SBIH "Clinical Rheumatological Hospital # 25"
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Saint-Petersburg, Sankt Petersburg, Russian Federation
LLC Medical Sanitary Unit
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Sankt-peterburg, Sankt Petersburg, Russian Federation
Center of Family Medicine LC
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Yekaterinburg, Sankt Petersburg, Russian Federation
SMMIH "Chelyabinsk Regional Clinical Hospital"
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Chelyabinsk, Voronez, Russian Federation
SEIHPE Saratov State Medical University n.a. V.I. Razumovskiy
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Saratov, Russian Federation
NIH "Departmental Hospital on Station Smolensk of OJSC "Russian Railways"
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Smolensk, Russian Federation
Limited Liability Company "Centre of Medical Common Practice"
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Novosibirsk, Russian Federation
SAHI of Kem. "Regional Clinical Hospital for War Veterans"
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Kemerovo, Russian Federation
OOO Family Polyclinic
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Korolev, Moscow Region, Russian Federation
Practical Medicine
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Moscow, Russian Federation
Lviv Regional Clinical Hospital Dept of Rehmuaatology D. Halytskyi Lviv NMU
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Lviv, KIEV Governorate, Ukraine
SHI Ulyanovsk Reg Clinical Hospital
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Ulyanovsk, Russian Federation
Institute of Rheumatology
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Belgrade, Serbia
Clinical Center Kragujevac
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Kragujevac, Serbia
General Hospital "Dr Laza K. Lazarevic" Sabac
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Sabac, Serbia
Siberian State Medical University
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Tomsk, Russian Federation
Territorial Clinical Hospital #2
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Vladivostok, Russian Federation
Special hospital for rheumatic diseases Novi Sad
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Novi Sad, Serbia
Medical Center of Limited Liability Company Medical Clinic Blagomed
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Kyiv, KIEV Governorate, Ukraine
GI L.T.Malaya Therapy National Institute of the NAMS of Ukraine
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Kharkiv, Ukraine
CI City Hospital #7
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Zaporizhzhia, Ukraine
CCBR Brasil Centro de Pesquisas e Análises Clínicas Ltda.
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Rio de Janeiro, RJ, Brazil
LMK Serviços Médicos S/S
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Porto Alegre, RS, Brazil
SBHI of Yaroslavl Region Clinical Hospital #3
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Yaroslavl, Volgograd, Russian Federation
MHAT "Hadzhi Dimitar", OOD
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Sliven, Bulgaria
Medical Center Excelsior OOD
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Sofia, Bulgaria
UMHAT "SofiaMed", OOD; Department of Neurology
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Sofia, Bulgaria
Medication Management
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Greensboro, North Carolina, United States
Saint Jude Heritage Medical Grp
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Fullerton, California, United States
RASF-Clinical Research Center
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Boca Raton, Florida, United States
Accurate Clinical Research
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Houston, Texas, United States
Clinical Research of West Florida
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Clearwater, Florida, United States
Oregon Health & Science Uni
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Portland, Oregon, United States
Baylor Research Inst.
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Dallas, Texas, United States
Metroplex Clinical Research Centre
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Dallas, Texas, United States
Centro de Investigaciones Medicas Mar Del Plata
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Mar del Plata, Argentina
Centro Medico Privado de Reumatologia; Reumathology
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San Miguel, Argentina
Instituto de Investigaciones Clinicas-Mar del Plata
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Buenos Aires, Argentina
Centro de Estudos em Terapias Inovadoras - CETI
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Curtiba, PR, Brazil
NMTH "Tsar Boris III"
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Sofia, Bulgaria
MC "Synexus - Sofia", EOOD
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Sofia, Bulgaria
Centro de Investigacion en Enfermedades Reumaticas y Osteoporosis
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Mexicali, Mexico
Ai Centrum Medyczne Sp. Z O.O Sp.K.
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Poznan, Poland
Centrum Medyczne AMED
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Warszawa, Poland
Medycyna Kliniczna
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Warszawa, Poland
CI of Healthcare Kharkiv CCH #8 Dept of Therapy Kharkiv MA of PGE of MOHU
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Kharkiv, Kharkiv Governorate, Ukraine
CI of TRC
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Ternopil, Kherson Governorate, Ukraine
A.Novak Transcarpathian Regional Clinical Hospital
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Uzhgorod, KIEV Governorate, Ukraine
Regional CH Dep of Rheumatology SHEI Ivano-Frankivsk NMU
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Ivano-Frankivsk, KIEV Governorate, Ukraine
MI of Healthcare Kyiv RCH P.L. Shupyk NMA of PGE
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Kyiv, Chernihiv Governorate, Ukraine
Med Center of International Institute of Clinical Trials LLC; Medical Center "OK!Clinic+"
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Kyiv, KIEV Governorate, Ukraine
CH of State Border Service of Ukraine (Military Base 2522); Dept of Therapy, D.Halytskyi Lviv NMU
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Lviv, KIEV Governorate, Ukraine
City Clinical Hospital #9 Dept of Therapy SI Zaporizhzhia MA of PGE of MoHU
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Zaporizhzhia, Tavria Okruha, Ukraine
M.V. Sklifosovsky Poltava RCH Dept of Rheumatology HSEIU UMSA
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Poltava, Ukraine
CI Lutsk CCH Volyn Regional Center of Cardiovascular Pathology and Thrombolysis
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Lutsk, Volhynian Governorate, Ukraine
Ultramed
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Omsk, Russian Federation
Railway Transp DCH of HealthCenter Branch of PJSC Ukr Railway Dept of Rheumatology
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Dnipro, Tavria Okruha, Ukraine
CI City Hospital #1
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Zaporizhzhia, Tavria Okruha, Ukraine
SI NSС M.D. Strazhesko Institute of Cardiology of NAMSU
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Kyiv, KIEV Governorate, Ukraine
Medical Center of Revmotsentr LLC
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Kyiv, KIEV Governorate, Ukraine
National Pirogov Memorial Medical University
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Vinnytsia, Podolia Governorate, Ukraine
CI Zaporizhzhia Regional Clinical Hospital of ZRC
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Zaporizhzhia, Ukraine
Szpital Uniwersytecki; nr 2 im. Dr J. Biziela
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Bydgoszcz, Poland