A Study of Tocilizumab in Patients With Rheumatoid Arthritis Who Have an Inadequate Response to Current Non-Biologic DMARDs

Phase 3

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: tocilizumab [RoActemra/Actemra]

• Registration Number: NCT00810277
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This single arm study will assess the safety and efficacy of tocilizumab in patients with moderate to severe active rheumatoid arthritis who have an inadequate response to current non-biologic DMARDs. Patients will receive iv infusions of tocilizumab 8mg/kg every 4 weeks for a total of 6 infusions, either as monotherapy or in combination with their current non-biologic DMARDs.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2008-11-30
• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-17
• Study First Posted: 2008-12-18
• Primary Completion: 2010-05-26
• Study Completion: 2010-05-26
• Results First Submitted: 2016-03-01
• Results First Submitted QC: 2016-03-01
• Results First Posted: 2016-03-31
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-28
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• adult patients, >=18 years of age;
• moderate to severe rheumatoid arthritis;
• inadequate response to current non-biologic DMARDs

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Exclusion Criteria

• rheumatic autoimmune disease or inflammatory joint disease other than rheumatoid arthritis;
• previous treatment with other biologics.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	tocilizumab [RoActemra/Actemra]	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events (AEs) or Serious Adverse Events (SAEs)	Baseline up to Week 24	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both serious as well as non-serious AEs.

Secondary Outcome Measures

Name	Time	Method
Disease Activity Score (DAS28)	Baseline, Weeks 4, 8, 12, 16, 20, and 24	DAS28 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joints count, erythrocyte sedimentation rate (ESR) (mm/hour) or C-reactive protein (CRP) (mg/dL), and general health (GH) status (measured on a 0 to 100 mm Visual Analogue Scale \[VAS\] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56\*square root (sqrt) (TJC28) + 0.28\*sqrt(SJC28) + 0.70\*natural logarithm (ln) (ESR) + 0.014\*GH of disease activity; DAS28-CRP = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(10\*CRP+1) + 0.014\*GH of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 \<=3.2 implied low disease activity, DAS \>3.2 to 5.1 implied moderate disease activity and DAS \>5.1 implied high disease activity, and DAS28 \<2.6 = clinical remission.
Percentage of Participants Achieving DAS28 Remission (DAS28 <2.6)	Weeks 4, 8, 12, 16, 20, and 24	DAS28 was calculated from SJC and TJC using 28 joints count, ESR (mm/hour) or CRP (mg/dL), and general health (GH) status (measured on a 0 to 100 mm Visual Analogue Scale \[VAS\] where 0=no disease activity and 100=worst disease activity). DAS28 was calculated using following formulas: DAS28-ESR = 0.56\*square root (sqrt) (TJC28) + 0.28\*sqrt(SJC28) + 0.70\*natural logarithm (ln) (ESR) + 0.014\*GH of disease activity; DAS28-CRP = 0.56\*sqrt(TJC28) + 0.28\*sqrt(SJC28) + 0.36\*ln(10\*CRP+1) + 0.014\*GH of disease activity. DAS28-ESR was adopted to calculate DAS28 if effective ESR data was available; otherwise DAS28-CRP was adopted to calculate DAS28. Total score range: 0-10, higher score=more disease activity. DAS28 \<=3.2 implied low disease activity, DAS \>3.2 to 5.1 implied moderate disease activity and DAS \>5.1 implied high disease activity, and DAS28 \<2.6 = clinical remission.
Percentage of Participants Achieving American College of Rheumatology (ACR) 20% (ACR20), ACR50 and ACR70 Response	Weeks 4, 8, 12, 16, 20, and 24	ACR20, ACR50, and ACR70 response: greater than or equal to (\>=) 20 percent (%), 50%, and 70% improvement respectively, in tender or swollen joint counts and in 3 of the following criteria: (1) Participant's assessment of pain (measured on a 0 to 100 mm VAS where 0=no pain and 100=unbearable pain); (2) Participant's assessment of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity); (3) Investigator's global assessment of disease activity (measured on a 0 to 100 mm VAS where 0=no disease activity and 100=worst disease activity); (4) Participant's assessment of functional disability via health assessment questionnaire (HAQ) (measured using 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities, 0=without difficulty to 3=unable to do).
C-Reactive Protein (CRP) Level	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Erythrocyte Sedimentation Rate (ESR)	Baseline, Weeks 4, 8, 12, 16, 20, and 24	The erythrocyte sedimentation rate (ESR) is the rate at which red blood cells sediment in a period of one hour.
Neutrophil Count	Baseline, Weeks 4, 8, and 12
Percentage of Participants Who Discontinued the Study	Up to Week 24
Percentage of Participants With Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Level Elevation More Than 1.5 Times Upper Limit of Normal	Up to Week 24	Normal range of ALT is 7 to 56 units per liter (U/L) of serum. Normal range of AST is 5 to 40 units per liter (U/L) of serum.
Percentage of Participants With Lipid Level Elevations	Week 24	Low density lipoprotein (LDL) level was categorized as 'Optimal (less than \[\<\] 100 milligram per deciliter \[mg/dL\])', 'Near Optimal/Above Optimal (100-129 mg/dL)', 'Borderline High (130-159 mg/dL)', 'High (160-189 mg/dL)', and 'Very high (190 mg/dL)'. High density lipoprotein (HDL) level was categorized as 'Acceptable (40-59 mg/dL)', 'High (\>=60 mg/dL)'. Total cholesterol (TC) level was categorized as 'Desirable (\<200 mg/dL)', 'Borderline High (200-239 mg/dL)', 'High (\>=240 mg/dL)'.

Trial Locations

Locations (3)

Kanta-Hämeen Keskussairaala ; Reumatologia; 🇫🇮 Hämeenlinna, Finland

Kiljavan Lääketutkimus Oy; 🇫🇮 Hyvinkää, Finland

Kanta-Hämeen keskussairaala; Riihimäen aluesairaala Reumapoliklinikka; 🇫🇮 Riihimäki, Finland