A Study of RoActemra/Actemra (Tocilizumab) With or Without Methotrexate in Patients With Mild to Moderate Rheumatoid Arthritis With an Inadequate Response to Methotrexate

Roche

Status and phase

Completed

Phase 3

Conditions

Rheumatoid Arthritis

Treatments

Drug: tocilizumab [RoActemra/Actemra]

Drug: methotrexate

Drug: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01587989

ML27837

2011-001863-39 (EudraCT Number)

Details and patient eligibility

About

This multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis, with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients with a good/moderate EULAR response will then be randomized to receive either RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12 weeks. Anticipated time on study treatment is 6 months.

Enrollment

77 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Adult patients, >/= 18 years of age
Rheumatoid arthritis of >/= 1 year duration
Mild to moderate disease activity at screening (DAS 28 </= 4.5 and >2.6)
On methotrexate treatment for at least 12 weeks, at stable oral dose of (10)15 mg to 25 mg/week for at least 6 weeks prior to Day 1
Body weight </= 150 kg
Oral corticosteroids must have been at stable dose (maximum 10 mg/day) for at least 25 out of 28 days prior to baseline

Exclusion criteria

Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline
Rheumatic autoimmune disease other than rheumatoid arthritis
Functional class IV American College of Rheumatology (ACR) Classification
Prior history of or current inflammatory joint disease other than rheumatoid arthritis
Treatment with a biologic agent at any time prior to baseline
Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline
Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline
Previous treatment with tocilizumab
Pregnant or lactating women
Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids
Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections
History of or currently active primary or secondary immunodeficiency
Evidence of active malignant disease, malignancies diagnosed within the previous 5 years
Active tuberculosis requiring treatment within the previous 3 years
Positive for HIV infection