Study To Evaluate The Safety And Efficacy Of ILV-094 In Subjects With Rheumatoid Arthritis
- Registration Number
- NCT00883896
- Lead Sponsor
- Pfizer
- Brief Summary
The primary objective of this study is to assess the safety and efficacy of different dose regimens of ILV-094 compared with placebo, administered subcutaneously to subjects with active rheumatoid arthritis who are taking methotrexate.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 195
- Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
- Active RA at the time of screening and baseline consisting of >= 5 swollen and >= 5 tender joints (28-joint count) and at least 1 of the following at screening: C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h
- Must be receiving methotrexate for at least 12 weeks, with a stable route and dose (up to 25 mg weekly) for at least 8 weeks prior to the baseline visit.
- Subjects with other rheumatic diseases
- Cancer or history of cancer (other than cutaneous basal cell carcinoma and squamous cell carcinoma or in situ cervical cancer)
- Any prior use of B cell-depleting therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 2 ILV-094 Part 1: 100 mg ILV-094 SC Q4W Arm 5 ILV-094 Part 2: 200 mg ILV-094 SC Q2W Arm 1 Placebo Part 1: Placebo Arm 3 ILV-094 Part 1: 100 mg ILV-094 SC Q2W Arm 4 Placebo -
- Primary Outcome Measures
Name Time Method Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 12 Week 12 ACR20 response: greater than or equal to (\>=) 20 percent improvement in tender joint count; \>=20 percent improvement in swollen joint count; and \>=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP).
- Secondary Outcome Measures
Name Time Method Percentage of Participants With an American College of Rheumatology 20 Percent (ACR20) Response at Week 2, 4, 6, 8 and 10 Week 2, 4, 6, 8, 10 ACR20 response: \>=20 percent improvement in tender joint count; \>=20 percent improvement in swollen joint count; and \>=20 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP).
Percentage of Participants With an American College of Rheumatology 70 Percent (ACR70) Response at Week 2, 4, 6, 8, 10 and 12 Week 2, 4, 6, 8, 10, 12 ACR70 response:\>=70 percent improvement in tender joint count; \>=70 percent improvement in swollen joint count; and 70 percent improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP).
Tender Joints Counts (TJC) Baseline, Week 2, 4, 6, 8, 10, 12 Number of tender joints was determined by examining 28 joints and identified the joints that were painful under pressure or to passive motion.
Disease Activity Score Based on 28-Joints Count (DAS28) Using C-Reactive Protein (CRP) Baseline, Week 2, 4, 6, 8, 10, 12 DAS28 (CRP) was calculated from number of swollen joints and tender joints using the 28 joints count; CRP (milligram/Liter \[mg/L\]); and general health visual analog scale (VAS) score (participant rated scale with scores ranging from 0mm \[very well\] to 100mm \[extremely bad\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 (CRP) less than or equal to (\<=) 3.2 implied low disease activity, greater than (\>) 3.2 to 5.1 implied moderate to high disease activity, and less than (\<) 2.6 implied remission.
Disease Activity Score Based on 28-Joints Count (DAS28) Using Erythrocyte Sedimentation Rate (ESR) Baseline, Week 2, 4, 6, 8, 10, 12 DAS28 (ESR) was calculated from the number of swollen joints and tender joints using the 28 joints count; ESR (millimeters per hour \[mm/hour\]); and general health VAS score (participant rated scale with scores ranging from 0 \[very well\] to 100 \[extremely bad\]). Total score range: 0 to 9.4, higher score indicated more disease activity. DAS28 (ESR) \<=3.2 implied low disease activity, \>3.2 to 5.1 implied moderate to high disease activity, and \<2.6 implied remission.
Percentage of Participants With an American College of Rheumatology 50 Percent (ACR50) Response at Week 2, 4, 6, 8, 10 and 12 Week 2, 4, 6, 8, 10, 12 ACR50 response: \>=50 percent improvement in tender joint count; \>=50 percent improvement in swollen joint count; and 50 improvement in 3 of 5 remaining ACR core measures: participant's global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); participant's assessment of pain (score: 0 \[very well\] to 100 \[extremely bad\]); physician global assessment of disease activity (score: 0 \[very well\] to 10 \[worst\]); self-assessed disability (disability index of the Health Assessment Questionnaire \[HAQ\]) (score: 0 \[no difficulty\] to 3 \[unable to do\]); and C-reactive protein (CRP).
Swollen Joints Count (SJC) Baseline, Week 2, 4, 6, 8, 10, 12 Number of swollen joints was determined by examination of 28 joints and identifying when swelling was present.
Physician Global Assessment of Disease Activity Baseline, Week 2, 4, 6, 8, 10, 12 Physician global assessment of disease activity was measured on an 11-point scale, ranging from 0 to 10, where 0 = no disease activity and 10 = extreme disease activity.
Participant Global Assessment of Disease Activity Baseline, Week 2, 4, 6, 8, 10, 12 Participants answered: "considering all the ways your arthritis affects you, how are you feeling today?" Participants responded by using a scale ranging from 0 to 10, where 0 = no disease activity and 10 = extreme disease activity.
Pain Visual Analog Scale (VAS) Baseline, Week 2, 4, 6, 8, 10, 12 Participants assessed the amount of pain currently experienced by them on a 100 millimeter (mm) VAS ranging from 0= no pain to 100= severe pain.
General Health Visual Analog Scale (VAS) Baseline, Week 2, 4, 6, 8, 10, 12 General health VAS is a 100 mm line marked by the participant. Participants were asked, "In general how would you rate your health currently concerning the arthritis?" Scores ranged from 0 mm = very well to 100 mm = extremely bad.
Health Assessment Questionnaire-Disability Index (HAQ-DI) Score Baseline, Week 4, 2, 6, 8, 10, 12 Health assessment questionnaire-disability index (HAQ-DI): participant-reported assessment of ability to perform tasks in 8 categories of daily living activities: dress/groom; arise; eat; walk; reach; grip; hygiene; and common activities over past week. Each item scored on 4-point scale from 0 to 3: 0=no difficulty; 1=some difficulty; 2=much difficulty; 3=unable to perform activity. Overall score was computed as the sum of domain scores and divided by the number of domains answered. Total possible score range 0-3 where 0 = least difficulty and 3 = extreme difficulty.
36-Item Short-Form Health Survey (SF-36) Baseline, Week 4, 8, 12 SF-36 is a standardized survey consisting of 36 items summarized into 8 multi-item scales evaluating 8 aspects of functional health and well-being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality and mental health. Two summary scores, the physical component summary (PCS) and the mental component summary (MCS) derived are derived by aggregating the 8 aspects. The score for each aspect and physical and mental component summary are scaled 0-100 where, higher score indicating highest level of functioning.
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale Baseline, Week 4, 8, 12 FACIT-fatigue is a 13-item questionnaire. Participants score each item on a 5-point scale ranging from 0 (not at all) to 4 (very much). The scoring algorithm is such that the item responses are reversed in score (except for 2 items, "I have energy" and "I am able to do my usual activities"), in order to reflect higher scores as less fatigue. The sum of all responses resulted in the FACIT-fatigue total score for a total possible score of 0 (worse score) to 52 (better score). A higher score reflected an improvement in the participant's health status.
Number of Participants With European League Against Rheumatism (EULAR) Response Based on DAS28 Week 2, 4, 6, 8, 10, 12 DAS28-based EULAR response criteria was used to measure individual response as none, good and moderate, depending on the extent of change from baseline and the level of disease activity reached. Good responders: change from baseline \>1.2 with DAS28 =\< 3.2; moderate responders: change from baseline \>1.2 with DAS28 \>3.2 to =\<5.1 or change from baseline \>0.6 to =\<1.2 with DAS28 =\<5.1; non-responders: change from baseline =\< 0.6 or change from baseline \>0.6 and =\<1.2 with DAS28 \>5.1.
Trial Locations
- Locations (52)
Deaconess Hospital
🇺🇸Cincinnati, Ohio, United States
Chu Liege Sart Tilman B 35
🇧🇪Liege, Belgium
Clinical Research Advantage, Inc.
🇺🇸Sarasota, Florida, United States
The Arthritis Specialty Centre
🇺🇸Sarasota, Florida, United States
Arthritis Care and Diagnostic Center
🇺🇸Dallas, Texas, United States
Desert Medical Advances
🇺🇸Palm Desert, California, United States
Arthritis Center
🇺🇸Palm Harbor, Florida, United States
University Hospital Centre Rijeka
ðŸ‡ðŸ‡·Rijeka, Croatia
University Hospital Center Zagreb
ðŸ‡ðŸ‡·Zagreb, Croatia
Reuma Instituut
🇧🇪Hasselt, Belgium
Clayton Medical Research
🇺🇸Saint Louis, Missouri, United States
Centro de Reumatologia y Ortopedia
🇨🇴Barranquilla, Atlantico, Colombia
AZ Jan Palfijn
🇧🇪Antwerpen, Belgium
Matsubara Clinic
🇯🇵Hyogo, Japan
Clinical Research Center of Reading
🇺🇸West Reading, Pennsylvania, United States
Cliniques Universitaires St Luc Avenue Hippocrate 10 UCL
🇧🇪Brussels, Belgium
Universitair Ziekenhuis Gent
🇧🇪Gent, Belgium
Klinikum Innenstadt der Ludwig-Maximillians-Universität
🇩🇪München, Germany
Spitalul Clinic Colentina
🇷🇴Bucuresti, Romania
Budai Irgalmasrendi Hospital
ðŸ‡ðŸ‡ºBudapest, Hungary
Obudai Egeszsegugyi Centrum Kft
ðŸ‡ðŸ‡ºBudapest, Hungary
Josa Andras Oktatokorhaz Egeszsegugyi Szolgaltato Nonprofit Kft.
ðŸ‡ðŸ‡ºNyiregyhaza, Hungary
Markusovszky Hospital
ðŸ‡ðŸ‡ºSzombathely, Hungary
Gunma University Hospital
🇯🇵Maebashi, Gunma, Japan
Municipal Institution City Clinical Hospital #40
🇷🇺Ekaterinburg, Russian Federation
State Health care institution of Leningrad Regional Clinical Hospital
🇷🇺Saint Petersburg, Russian Federation
Arthritis & Osteoporosis Center of South Texas
🇺🇸San Antonio, Texas, United States
National Hospital Organization Shimoshizu National Hospital
🇯🇵Yotsukaidou, Chiba, Japan
Medical Corporation Wakoukai Kurashiki Kousai Hospital
🇯🇵Kurashiki, Okayama, Japan
Inoue Hospital
🇯🇵Gunma, Japan
Matsubara Mayflower Hospital
🇯🇵Hyogo, Japan
Altoona Center for Clinical Research
🇺🇸Duncansville, Pennsylvania, United States
Diagnostic Rheumatology and Research PC
🇺🇸Indianapolis, Indiana, United States
Arizona Arthritis & Rheumatology Research, PLLC
🇺🇸Glendale, Arizona, United States
Clinical Research Center of Reading, LLC
🇺🇸Wyomissing, Pennsylvania, United States
Servimed EU
🇨🇴Bucaramanga, Santander, Colombia
National Hospital Organization Sagamihara National Hospital
🇯🇵Sagamihara, Kanagawa, Japan
State Healthcare Institution Yaroslavl Regional Clinical Hospital
🇷🇺Yaroslavl, Russian Federation
State Educational Institution of Additional Professional Education
🇷🇺Saint Petersburg, Russian Federation
State education institution of higher vocational education Smolensk State Medical Academy Roszdrav
🇷🇺Smolensk, Russian Federation
City Clinical Hospital # 1 n.a. Pirogov
🇷🇺Moscow, Russian Federation
Centro de Estudio de Investigacion Basica y Clinica S.C
🇲🇽Jalisco, Guadalajara, Mexico
Centrul Medical Terra Med
🇷🇴Cluj-Napoca, Cluj, Romania
Medicity S.A.S
🇨🇴Bucaramanga, Santander, Colombia
Spitalul Clinic Sf. Maria
🇷🇴Bucuresti, Romania
Fundacion Instituto de Reumatologia Fernando Chalem
🇨🇴Bogota, Cundinamarca, Colombia
Spitalul Clinic Judetean de Urgenta Tg Mures
🇷🇴Targu Mures, Romania
Institute of Rheumatology, Tokyo Women's Medical University Hospital
🇯🇵Shinjyuku-ku, Tokyo, Japan
Centrul de Boli Reumatismale Dr. I. Stoia
🇷🇴Bucuresti, Romania
SC Duo Medical SRL
🇷🇴Bucuresti, Romania
Institute of Rheumatology of Russian academy of Medical Scie
🇷🇺Moscow, Russian Federation
AMC
🇳🇱Amsterdam, Noord-Holland, Netherlands