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

• Status: Withdrawn
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Methotrexate

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