A Canadian Study to Evaluate Early Use of Adalimumab After Methotrexate Failure in Early Rheumatoid Arthritis (RADAR)
This study is currently recruiting participants.
Verified March 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Collaborator:
Mount Sinai Hospital, Canada
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01162421
First received: May 25, 2010
Last updated: March 15, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Arthritis, Rheumatoid |
Biological: adalimumab Drug: Methotrexate |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by AbbVie:
Primary Outcome Measures:
- Effectiveness in reducing joint damage using the Van Der Heijde modified Total Sharp Score (mTSS) [ Time Frame: Month 24 ] [ Designated as safety issue: No ]Proportion of subjects with no radiographic progression defined as ΔmTSS ≤ 0.5 unit
Secondary Outcome Measures:
- Effectiveness in reducing joint damage using the Van Der Heijde modified Total Sharp Score (mTSS) [ Time Frame: Month 12 ] [ Designated as safety issue: No ]Proportion of subjects with no radiographic progression defined as ΔmTSS ≤ 0.5 unit
- Effectiveness in reducing joint damage by the change in mTSS [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
- Effectiveness in reducing joint damage by the change in mTSS [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
- Effectiveness in achieving therapeutic response as measured by the ACR 20 / 50 / 70 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]American College of Rheumatology (ACR) improvement criteria
- Effectiveness in achieving DAS28 Remission [ Time Frame: Month 24 ] [ Designated as safety issue: No ]Disease Activity Score using 28 joint counts (DAS 28)
- Effectiveness in improving functional status as measured by the change in Health Assessment Questionnaire (HAQ) [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
- Effectiveness in improving work related productivity as measured by the Work Limitation Questionnaire (WLQ) [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
- Effectiveness in improving Quality of Life as measured by the EuroQol (EQ-5D) [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
- Effectiveness in reducing fatigue as measured by the change in FACIT-Fatigue Scale [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
- Effectiveness in achieving a therapeutic response as measured by the EULAR response [ Time Frame: Month 24 ] [ Designated as safety issue: No ]European League Against Rheumatism (EULAR)
- Effectiveness in reducing Swollen Joint Count and Tender Joint Count [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 320 |
| Study Start Date: | May 2010 |
| Estimated Study Completion Date: | October 2017 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Early Adalimumab
Patients in the Early Adalimumab arm will receive adalimumab and methotrexate at Baseline and every other week for study duration.
|
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.
Other Name: ABT-D2E7 Humira
Drug: Methotrexate
Patients in both arms will receive a methotrexate regimen based on local guidelines and their study doctor's judgment.
Other Name: Trexall Rheumatrex
|
|
Active Comparator: Standard of Care (SOC)
Patients 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.
|
Drug: Methotrexate
Patients in both arms will receive a methotrexate regimen based on local guidelines and their study doctor's judgment.
Other Name: Trexall Rheumatrex
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subject is >= 18 years of age.
- 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.
- 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).
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 (ESR) >= 20 mm/1h or C-Reactive Protein (CRP) >upper limit of normal (ULN).
Subject must fulfill at least one of the following three criteria:
- History of Rheumatoid Factor (RF) positive
- History of at least one erosion on X-ray or Magnetic Resonance Imaging (MRI)
- History of anti-CCP (anti-citrullinated Protein) Antibody positive.
Exclusion Criteria:
- Subject has previous exposure to any biologic therapy including adalimumab.
- Prior Disease-modifying antirheumatic drugs (DMARD) triple therapy with Methotrexate.
- 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.
- Subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study) of baseline.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01162421
Contacts
| Contact: Fanie Wilson | 1-888-703-3006, ext 7195 | fanie.wilson@abbvie.com |
| Contact: Sophie Desjardins | 1-888-703-3006, ext 7305 | sophie.desjardins@abbvie.com |
Locations
| Canada | |
| Site Reference ID/Investigator# 37962 | Recruiting |
| Brampton, Canada, L6T 3J1 | |
| Principal Investigator: Site Reference ID/Investigator# 37962 | |
| Site Reference ID/Investigator# 37972 | Recruiting |
| Burlington, Canada, L7R 1E2 | |
| Principal Investigator: Site Reference ID/Investigator# 37972 | |
| Site Reference ID/Investigator# 55325 | Recruiting |
| Calgary, Canada, AB T2N 4N1 | |
| Principal Investigator: Site Reference ID/Investigator# 55325 | |
| Site Reference ID/Investigator# 37975 | Recruiting |
| Edmonton, Canada, T5M 0H4 | |
| Principal Investigator: Site Reference ID/Investigator# 37975 | |
| Site Reference ID/Investigator# 37968 | Recruiting |
| Halifax, Canada, B3H 4K4 | |
| Principal Investigator: Site Reference ID/Investigator# 37968 | |
| Site Reference ID/Investigator# 37967 | Recruiting |
| Hamilton, Canada, L8N 2B6 | |
| Principal Investigator: Site Reference ID/Investigator# 37967 | |
| Site Reference ID/Investigator# 37965 | Recruiting |
| Hamilton, Canada, L8N 1Y2 | |
| Principal Investigator: Site Reference ID/Investigator# 37965 | |
| Site Reference ID/Investigator# 38429 | Recruiting |
| Kelowna, Canada, V1Y 3G8 | |
| Principal Investigator: Site Reference ID/Investigator# 38429 | |
| Site Reference ID/Investigator# 37966 | Recruiting |
| Mississauga, Canada, L5M 2V8 | |
| Principal Investigator: Site Reference ID/Investigator# 37966 | |
| Site Reference ID/Investigator# 37973 | Completed |
| Montreal, Canada, H3Z 2Z3 | |
| Site Reference ID/Investigator# 37969 | Recruiting |
| Montreal, Canada, H2L 1S6 | |
| Principal Investigator: Site Reference ID/Investigator# 37969 | |
| Site Reference ID/Investigator# 37974 | Recruiting |
| Newmarket, Canada, L3Y 3R7 | |
| Principal Investigator: Site Reference ID/Investigator# 37974 | |
| Site Reference ID/Investigator# 37978 | Withdrawn |
| Ottawa, Canada, K1S 1C2 | |
| Site Reference ID/Investigator# 45042 | Recruiting |
| Penticton, Canada, V2A 3G7 | |
| Principal Investigator: Site Reference ID/Investigator# 45042 | |
| Site Reference ID/Investigator# 38428 | Recruiting |
| Quispamsis, Canada, E2E 4J8 | |
| Principal Investigator: Site Reference ID/Investigator# 38428 | |
| Site Reference ID/Investigator# 41487 | Recruiting |
| Rimouski, Canada, G5L 8W1 | |
| Principal Investigator: Site Reference ID/Investigator# 41487 | |
| Site Reference ID/Investigator# 74913 | Recruiting |
| Saint-Jerome, Canada, J7Z 5T3 | |
| Principal Investigator: Site Reference ID/Investigator# 74913 | |
| Site Reference ID/Investigator# 43602 | Recruiting |
| Saskatoon, Canada, S7K 3H3 | |
| Principal Investigator: Site Reference ID/Investigator# 43602 | |
| Site Reference ID/Investigator# 40207 | Recruiting |
| St. Eustache, Canada, J7P 4J2 | |
| Principal Investigator: Site Reference ID/Investigator# 40207 | |
| Site Reference ID/Investigator# 54245 | Recruiting |
| St. John's, Canada, A1A 5E8 | |
| Principal Investigator: Site Reference ID/Investigator# 54245 | |
| Site Reference ID/Investigator# 37970 | Recruiting |
| Toronto, Canada, M9C 5N2 | |
| Principal Investigator: Site Reference ID/Investigator# 37970 | |
| Site Reference ID/Investigator# 53383 | Recruiting |
| Vancouver, Canada, V5Z 1L7 | |
| Principal Investigator: Site Reference ID/Investigator# 53383 | |
| Site Reference ID/Investigator# 37964 | Recruiting |
| Victoria, Canada, V8V 3P9 | |
| Principal Investigator: Site Reference ID/Investigator# 37964 | |
| Site Reference ID/Investigator# 41934 | Recruiting |
| Victoria, Canada, V8V 3N7 | |
| Principal Investigator: Site Reference ID/Investigator# 41934 | |
| Site Reference ID/Investigator# 37971 | Recruiting |
| Winnipeg, Canada, R3A 1M3 | |
| Principal Investigator: Site Reference ID/Investigator# 37971 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Mount Sinai Hospital, Canada
Investigators
| Study Director: | Linda Assouline, PhD | AbbVie Corporation |
More Information
Additional Information:
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01162421 History of Changes |
| Other Study ID Numbers: | W12-122 |
| Study First Received: | May 25, 2010 |
| Last Updated: | March 15, 2013 |
| Health Authority: | Canada: Health Canada |
Keywords provided by AbbVie:
|
Biological Therapy adalimumab Rheumatoid Arthritis Antirheumatic Agents |
Anti-Inflammatory Disease-Modifying Antirheumatic Drugs, Agents |
Additional relevant MeSH terms:
|
Arthritis, Rheumatoid Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Adalimumab Antirheumatic Agents Methotrexate Therapeutic Uses Pharmacologic Actions Abortifacient Agents, Nonsteroidal |
Abortifacient Agents Reproductive Control Agents Physiological Effects of Drugs Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Dermatologic Agents Enzyme Inhibitors Folic Acid Antagonists Immunosuppressive Agents Immunologic Factors Nucleic Acid Synthesis Inhibitors Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 23, 2013