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

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: adalimumab (Biological); Methotrexate (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Linda Assouline, PhD, Study Director, Affiliation: AbbVie Corporation

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.

Clinical Details

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

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

Primary outcome: Effectiveness in reducing joint damage using the Van Der Heijde modified Total Sharp Score (mTSS)

Secondary outcome:

Effectiveness in reducing joint damage using the Van Der Heijde modified Total Sharp Score (mTSS)

Effectiveness in reducing joint damage by the change in mTSS

Effectiveness in reducing joint damage by the change in mTSS

Effectiveness in achieving therapeutic response as measured by the ACR 20 / 50 / 70

Effectiveness in achieving DAS28 Remission

Effectiveness in improving functional status as measured by the change in Health Assessment Questionnaire (HAQ)

Effectiveness in improving work related productivity as measured by the Work Limitation Questionnaire (WLQ)

Effectiveness in improving Quality of Life as measured by the EuroQol (EQ-5D)

Effectiveness in reducing fatigue as measured by the change in FACIT-Fatigue Scale

Effectiveness in achieving a therapeutic response as measured by the EULAR response

Effectiveness in reducing Swollen Joint Count and Tender Joint Count

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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): 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.

Locations and Contacts

Site Reference ID/Investigator# 37962, Brampton L6T 3J1, Canada

Site Reference ID/Investigator# 37972, Burlington L7R 1E2, Canada

Site Reference ID/Investigator# 55325, Calgary AB T2N 4N1, Canada

Site Reference ID/Investigator# 37975, Edmonton T5M 0H4, Canada

Site Reference ID/Investigator# 37968, Halifax B3H 4K4, Canada

Site Reference ID/Investigator# 37965, Hamilton L8N 1Y2, Canada

Site Reference ID/Investigator# 37967, Hamilton L8N 2B6, Canada

Site Reference ID/Investigator# 38429, Kelowna V1Y 3G8, Canada

Site Reference ID/Investigator# 37966, Mississauga L5M 2V8, Canada

Site Reference ID/Investigator# 37973, Montreal H3Z 2Z3, Canada

Site Reference ID/Investigator# 37974, Newmarket L3Y 3R7, Canada

Site Reference ID/Investigator# 45042, Penticton V2A 3G7, Canada

Site Reference ID/Investigator# 38428, Quispamsis E2E 4J8, Canada

Site Reference ID/Investigator# 41487, Rimouski G5L 8W1, Canada

Site Reference ID/Investigator# 43602, Saskatoon S7K 3H3, Canada

Site Reference ID/Investigator# 54245, St. John's A1A 5E8, Canada

Site Reference ID/Investigator# 26922, Toronto M5T 3L9, Canada

Site Reference ID/Investigator# 37970, Toronto M9C 5N2, Canada

Site Reference ID/Investigator# 53383, Vancouver V5Z 1L7, Canada

Site Reference ID/Investigator# 37964, Victoria V8V 3P9, Canada

Site Reference ID/Investigator# 41934, Victoria V8V 3N7, Canada

Site Reference ID/Investigator# 37971, Winnipeg R3A 1M3, Canada

Additional Information

Starting date: May 2010
Last updated: August 4, 2015

Page last updated: August 23, 2015

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