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
Information source: Hoffmann-La Roche
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: methotrexate (Drug); tocilizumab [RoActemra/Actemra] (Drug)
Phase: Phase 4
Status: Withdrawn
Sponsored by: Hoffmann-La Roche Official(s) and/or principal investigator(s): Clinical Trials, Study Director, Affiliation: Hoffmann-La Roche
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.
Clinical Details
Official title: Open Label Study to Describe the Effect of Tocilizumab in Combination With MTX in the Evolution of Articular Damage (Synovitis/Osteitis and Erosions) Evaluated by MRI in the Hand of Patients With Moderate to Severe Rheumatoid Arthritis (RA) and Inadequate Response to Non-biological DMARDs
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Change in extent and degree of synovitis in the hand assessed by MRI according to the OMERACT RAMRIS scale
Secondary outcome: Radiological changes in the hand according to the modified Sharp scaleChange in Ritchie articular index Proportion of patients with American College of Rheumatology (ACR 20/50/70) response at Weeks 12 and 24 Change in pain: Visual analogue scale (VAS) Change in disability: Stanford Health Assessment Questionnaire Change in FACIT-fatigue questionnaire Change in disease activity: Disease activity score 28 - erythrocyte sedimentation rate (DAS28-ESR) Change in C-reactive protein Change in immunologic parameters: Rheumatic factor/anti-CCP Safety: Incidence of adverse events
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
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
Locations and Contacts
Additional Information
Starting date: June 2013
Last updated: August 17, 2015
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