A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis

NCT ID: NCT01162421

Last Updated: 2016-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 77 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2015-07-31

Brief Summary

A Canadian study to evaluate early use of adalimumab after methotrexate failure in early rheumatoid arthritis. The study hypothesis will verify if adalimumab effectively reduces joint damage in more participants when introduced earlier than in current practice.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; Anti-Inflammatory; Biological Therapy; adalimumab; Disease-Modifying Antirheumatic Drugs; Antirheumatic Agents; Agents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early Adalimumab

Participants in the Early Adalimumab arm will receive adalimumab and methotrexate at Baseline and every other week for study duration.

Group Type: EXPERIMENTAL

adalimumab

Intervention Type: BIOLOGICAL

Study drug will be provided to participants in Early Adalimumab arm as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). 40 mg of adalimumab will be administered subcutaneously at Baseline and then every other week for 24 months. Adalimumab may be initiated in participants in standard of care (SOC) arm after a minimum of 6 months of treatment recommended by their study doctor.

Methotrexate

Intervention Type: DRUG

Participants in both arms will receive a methotrexate regimen based on local guidelines and their study doctor's judgment.

Standard of Care

Participants in the Standard of Care arm will receive methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may be initiated after a minimum of 6 months.

Group Type: ACTIVE_COMPARATOR

adalimumab

Intervention Type: BIOLOGICAL

Study drug will be provided to participants in Early Adalimumab arm as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). 40 mg of adalimumab will be administered subcutaneously at Baseline and then every other week for 24 months. Adalimumab may be initiated in participants in standard of care (SOC) arm after a minimum of 6 months of treatment recommended by their study doctor.

Methotrexate

Intervention Type: DRUG

Participants in both arms will receive a methotrexate regimen based on local guidelines and their study doctor's judgment.

Interventions

adalimumab

Study drug will be provided to participants in Early Adalimumab arm as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). 40 mg of adalimumab will be administered subcutaneously at Baseline and then every other week for 24 months. Adalimumab may be initiated in participants in standard of care (SOC) arm after a minimum of 6 months of treatment recommended by their study doctor.

Intervention Type: BIOLOGICAL

Methotrexate

Participants in both arms will receive a methotrexate regimen based on local guidelines and their study doctor's judgment.

Intervention Type: DRUG

Other Intervention Names

ABT-D2E7; Humira; Trexall; Rheumatrex

Eligibility Criteria

Inclusion Criteria

1. Subject has a diagnosis of Rheumatoid Arthritis as defined by the 1987-revised American College of Rheumatology-classification criteria and has disease duration of less than 2 years from diagnosis.

2. Subject must have been on a dose of methotrexate therapy either subcutaneously or orally administered (15-25 mg/week) for at least 3 months prior to baseline visit and has had an inadequate response to treatment defined as having a Disease Activity Score DAS28 > 3.2 (at Screening visit).

3. Subject must also meet the following three criteria (at screening visit): at least 4 swollen joints out of 66 assessed; at least 4 tender joints out of 68 assessed; subject must have an elevated erythrocyte sedimentation rate >/= 20 mm/1h or C-reactive protein > upper limit of normal.

4. Subject must fulfill at least one of the following three criteria: history of rheumatoid factor positive; history of at least one erosion on X-ray or magnetic resonance imaging; history of anti-cyclic-citrullinated protein antibody positive.

Exclusion Criteria

1. Subject has previous exposure to any biologic therapy including adalimumab.

2. Prior disease-modifying antirheumatic drugs triple therapy with methotrexate.

3. Subject has been treated with intra-articular or parenteral administration of corticosteroids in the preceding 4 weeks prior to baseline visit. Inhaled corticosteroids for stable medical conditions are allowed.

4. Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study) of Baseline.

5. Subject has a poorly controlled medical condition, such as uncontrolled diabetes, unstable heart disease, congestive heart failure, recent cerebrovascular accidents and any other condition which, in the opinion of the Investigator, would put the subject at risk by participating in the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mount Sinai Hospital, Canada

OTHER

Sponsor Role: collaborator

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christina Pelizon, MD

Role: STUDY_DIRECTOR

AbbVie Corporation

Countries

Canada

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

W12-122

Identifier Type: -

Identifier Source: org_study_id