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

Roche

Status and phase

Withdrawn

Phase 4

Conditions

Rheumatoid Arthritis

Treatments

Drug: methotrexate

Drug: tocilizumab [RoActemra/Actemra]

Study type

Interventional

Funder types

Industry

Identifiers

NCT01878318

ML28204

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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