A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy

Roche

Status and phase: Completed; Phase 3

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo; Drug: tocilizumab [RoActemra/Actemra]; Drug: Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00106522

WA18062

Details and patient eligibility

About

This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Enrollment: 499 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;
• inadequate response to current anti-rheumatic therapies, including MTX;
• inadequate response or intolerance to treatment with 1 or more anti-TNF therapies within 1 year of entering study;
• on stable MTX for at least 8 weeks before entering study;
• patients of reproductive potential must be using reliable methods of contraception.

Exclusion criteria

• major surgery (including joint surgery) within 8 weeks before screening, or planned major surgery within 6 months after entering study;
• women who are pregnant or breast-feeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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499 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: tocilizumab [RoActemra/Actemra]

Drug: Methotrexate

Drug: tocilizumab [RoActemra/Actemra]

2

Experimental group

Treatment:

Drug: tocilizumab [RoActemra/Actemra]

Drug: Methotrexate

Drug: tocilizumab [RoActemra/Actemra]

3

Placebo Comparator group

Treatment:

Drug: Placebo

Drug: Methotrexate