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

Rheumatoid Arthritis Clinical Trial

— RADAR  

Official title:

Radiographic, Clinical and Patient Outcomes in a Multicenter, Open Label Phase IV Randomized Trial of Earlier Adalimumab Introduction Therapy Versus Later Introduction as Per Standard of Care After Initial Methotrexate Failure in Early Rheumatoid Arthritis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01162421
• Other study ID #: W12-122
• Status: Completed
• Phase: Phase 4
• First received: May 25, 2010
• Last updated: August 4, 2015
• Start date: May 2010
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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 patients when introduced earlier than in current practice.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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):

3.1. At least 4 swollen joints out of 66 assessed. 3.2. At least 4 tender joints out of 68 assessed. 3.3. Subject must have an elevated Erythrocyte Sedimentation Rate (ESR) >= 20 mm/1h or C-Reactive Protein (CRP) >upper limit of normal (ULN).

4. Subject must fulfill at least one of the following three criteria:

4.1. History of Rheumatoid Factor (RF) positive 4.2. History of at least one erosion on X-ray or Magnetic Resonance Imaging (MRI) 4.3. History of anti-CCP (anti-citrullinated Protein) Antibody positive.

Exclusion Criteria:

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

2. Prior Disease-modifying antirheumatic drugs (DMARD) 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Biological:
• adalimumab
Study drug will be provided to patients 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. Patients in standard of care (SOC) arm will receive treatment recommended by their study doctor. Adalimumab may be initiated in SOC patients after a minimum of 6 months.

Drug:
• Methotrexate
Patients in both arms will receive a methotrexate regimen based on local guidelines and their study doctor's judgment.

Locations

Country	Name	City	State
Canada	Site Reference ID/Investigator# 37962	Brampton
Canada	Site Reference ID/Investigator# 37972	Burlington
Canada	Site Reference ID/Investigator# 55325	Calgary
Canada	Site Reference ID/Investigator# 37975	Edmonton
Canada	Site Reference ID/Investigator# 37968	Halifax
Canada	Site Reference ID/Investigator# 37965	Hamilton
Canada	Site Reference ID/Investigator# 37967	Hamilton
Canada	Site Reference ID/Investigator# 38429	Kelowna
Canada	Site Reference ID/Investigator# 37966	Mississauga
Canada	Site Reference ID/Investigator# 37973	Montreal
Canada	Site Reference ID/Investigator# 37974	Newmarket
Canada	Site Reference ID/Investigator# 45042	Penticton
Canada	Site Reference ID/Investigator# 38428	Quispamsis
Canada	Site Reference ID/Investigator# 41487	Rimouski
Canada	Site Reference ID/Investigator# 43602	Saskatoon
Canada	Site Reference ID/Investigator# 54245	St. John's
Canada	Site Reference ID/Investigator# 26922	Toronto
Canada	Site Reference ID/Investigator# 37970	Toronto
Canada	Site Reference ID/Investigator# 53383	Vancouver
Canada	Site Reference ID/Investigator# 37964	Victoria
Canada	Site Reference ID/Investigator# 41934	Victoria
Canada	Site Reference ID/Investigator# 37971	Winnipeg

Sponsors (2)

Lead Sponsor	Collaborator
AbbVie (prior sponsor, Abbott)	Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness in reducing joint damage using the Van Der Heijde modified Total Sharp Score (mTSS)	Proportion of subjects with no radiographic progression defined as ?mTSS = 0.5 unit	Month 24	No
Secondary	Effectiveness in reducing joint damage using the Van Der Heijde modified Total Sharp Score (mTSS)	Proportion of subjects with no radiographic progression defined as ?mTSS = 0.5 unit	Month 12	No
Secondary	Effectiveness in reducing joint damage by the change in mTSS		Month 12	No
Secondary	Effectiveness in reducing joint damage by the change in mTSS		Month 24	No
Secondary	Effectiveness in achieving therapeutic response as measured by the ACR 20 / 50 / 70	American College of Rheumatology (ACR) improvement criteria	Month 24	No
Secondary	Effectiveness in achieving DAS28 Remission	Disease Activity Score using 28 joint counts (DAS 28)	Month 24	No
Secondary	Effectiveness in improving functional status as measured by the change in Health Assessment Questionnaire (HAQ)		Month 24	No
Secondary	Effectiveness in improving work related productivity as measured by the Work Limitation Questionnaire (WLQ)		Month 24	No
Secondary	Effectiveness in improving Quality of Life as measured by the EuroQol (EQ-5D)		Month 24	No
Secondary	Effectiveness in reducing fatigue as measured by the change in FACIT-Fatigue Scale		Month 24	No
Secondary	Effectiveness in achieving a therapeutic response as measured by the EULAR response	European League Against Rheumatism (EULAR)	Month 24	No
Secondary	Effectiveness in reducing Swollen Joint Count and Tender Joint Count		Month 24	No

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