Status:
WITHDRAWN
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
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 mode...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01878318
Start Date
June 1 2013
End Date
June 1 2015
Last Update
November 2 2016
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