A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs

Phase 4

Withdrawn

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

• Registration Number: NCT01878318
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This open-label, single arm study will evaluate the effect of RoActemra/Actemra in combination with methotrexate on articular damage in the hand (synovitis/osteitis and erosions) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to non-biological disease-modifying ante-rheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for 24 weeks.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-06-06
• Study First Submitted QC: 2013-06-12
• Study First Posted: 2013-06-14
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adult patients, >/= 18 years of age
• Diagnosis of rheumatoid arthritis according to ACR/EULAR classification (2010) of >/= 6 months duration
• Active moderate to severe rheumatoid arthritis (DAS >/= 3.2)
• Swollen joint count (SJC) >/= 6, tender joint count >/= 8
• Synovitis in the dominant hand
• Inadequate response to stable dose of a non-biological DMARD for at least 3 months
• Oral corticosteroids must have been on stable dose for at least 25 out of 28 days before first dose of study drug
• Patient on outpatient treatment

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Exclusion Criteria

• Major surgery (including joint surgery) in the 8 weeks prior to screening, or planned major surgery within 6 months of randomization
• Rheumatic autoimmune disease other than rheumatoid arthritis
• American College of Rheumatology (ACR) functional class IV
• History of or current inflammatory joint disease other than rheumatoid arthritis
• Previous inadequate response to a biologic DMARD; prior biologic therapy for no longer than 1 month is allowed if discontinued for reasons of tolerability at least 6 months prior to study recruitment
• Intra-articular or parenteral corticosteroids within 6 weeks prior to study start
• Inadequate hematologic, renal or liver function
• Positive for hepatitis B, hepatitis C or HIV infection
• Pregnant or lactating women
• History of severe allergic reactions or anaphylaxis to human, humanized or mural monoclonal antibodies
• Current infections or history of recurrent infections
• History of or currently active primary or acquired immunodeficiency
• Active tuberculosis requiring treatment in the previous 3 years
• Body weight > 150 kg

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RoActemra/Actemra	tocilizumab [RoActemra/Actemra]	-
RoActemra/Actemra	methotrexate	-

Primary Outcome Measures

Name	Time	Method
Change in extent and degree of synovitis in the hand assessed by MRI according to the OMERACT RAMRIS scale	from baseline to Week 24

Secondary Outcome Measures

Name	Time	Method
Radiological changes in the hand according to the modified Sharp scale	from baseline to Week 24
Change in disability: Stanford Health Assessment Questionnaire	from baseline to Week 24
Change in Ritchie articular index	from baseline to Week 24
Proportion of patients with American College of Rheumatology (ACR 20/50/70) response at Weeks 12 and 24	Weeks 12 and 24
Change in pain: Visual analogue scale (VAS)	from baseline to Week 24
Change in FACIT-fatigue questionnaire	from baseline to Week 24
Change in disease activity: Disease activity score 28 - erythrocyte sedimentation rate (DAS28-ESR)	from baseline to Week 28
Change in immunologic parameters: Rheumatic factor/anti-CCP	from baseline to Week 24
Safety: Incidence of adverse events	approximately 2 years
Change in C-reactive protein	from baseline to Week 24