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

NCT ID: NCT01587989

Last Updated: 2015-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2014-02-28

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

A Methotrexate

Group Type: ACTIVE_COMPARATOR

methotrexate

Intervention Type: DRUG

15-25 mg orally weekly, Weeks 1-12

methotrexate

Intervention Type: DRUG

15-25 mg orally weekly, Weeks 13-24

tocilizumab [RoActemra/Actemra]

Intervention Type: DRUG

8 mg/kg iv every 4 weeks, 24 weeks

B Methotrexate Placebo

Group Type: EXPERIMENTAL

methotrexate

Intervention Type: DRUG

15-25 mg orally weekly, Weeks 1-12

placebo

Intervention Type: DRUG

methotrexate placebo orally weekly, Weeks 13-24

tocilizumab [RoActemra/Actemra]

Intervention Type: DRUG

8 mg/kg iv every 4 weeks, 24 weeks

Interventions

methotrexate

15-25 mg orally weekly, Weeks 1-12

Intervention Type: DRUG

methotrexate

15-25 mg orally weekly, Weeks 13-24

Intervention Type: DRUG

placebo

methotrexate placebo orally weekly, Weeks 13-24

Intervention Type: DRUG

tocilizumab [RoActemra/Actemra]

8 mg/kg iv every 4 weeks, 24 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Graz, , Austria

Graz-Eggenberg, , Austria

Hollabrunn, , Austria

Innsbruck, , Austria

Linz, , Austria

Salzburg, , Austria

Stockerau, , Austria

Vienna, , Austria

Vienna, , Austria

Vienna, , Austria

Vienna, , Austria

Vienna, , Austria

Wels, , Austria

Countries

Austria

Other Identifiers

2011-001863-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ML27837

Identifier Type: -

Identifier Source: org_study_id