Clinical trial NCT01878318: 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
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 type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-06-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change in extent and degree of synovitis in the hand assessed by MRI according to the OMERACT RAMRIS scale
timeFrame: from baseline to Week 24
Secondary outcomes:
measure: Radiological changes in the hand according to the modified Sharp scale
timeFrame: from baseline to Week 24
measure: Change in Ritchie articular index
timeFrame: from baseline to Week 24
measure: Proportion of patients with American College of Rheumatology (ACR 20/50/70) response at Weeks 12 and 24
timeFrame: Weeks 12 and 24
measure: Change in pain: Visual analogue scale (VAS)
timeFrame: from baseline to Week 24
measure: Change in disability: Stanford Health Assessment Questionnaire
timeFrame: from baseline to Week 24
measure: Change in FACIT-fatigue questionnaire
timeFrame: from baseline to Week 24
measure: Change in disease activity: Disease activity score 28 - erythrocyte sedimentation rate (DAS28-ESR)
timeFrame: from baseline to Week 28
measure: Change in C-reactive protein
timeFrame: from baseline to Week 24
measure: Change in immunologic parameters: Rheumatic factor/anti-CCP
timeFrame: from baseline to Week 24
measure: Safety: Incidence of adverse events
timeFrame: approximately 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: