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

This study is ongoing, but not recruiting participants.
Sponsor:
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: January 26, 2015
Last verified: January 2015
  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
Rheumatoid Arthritis
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: July 2015
Estimated Primary Completion Date: July 2015 (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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01162421

Locations
Canada
Site Reference ID/Investigator# 37962
Brampton, Canada, L6T 3J1
Site Reference ID/Investigator# 37972
Burlington, Canada, L7R 1E2
Site Reference ID/Investigator# 55325
Calgary, Canada, AB T2N 4N1
Site Reference ID/Investigator# 37975
Edmonton, Canada, T5M 0H4
Site Reference ID/Investigator# 37968
Halifax, Canada, B3H 4K4
Site Reference ID/Investigator# 37967
Hamilton, Canada, L8N 2B6
Site Reference ID/Investigator# 37965
Hamilton, Canada, L8N 1Y2
Site Reference ID/Investigator# 38429
Kelowna, Canada, V1Y 3G8
Site Reference ID/Investigator# 37966
Mississauga, Canada, L5M 2V8
Site Reference ID/Investigator# 37973
Montreal, Canada, H3Z 2Z3
Site Reference ID/Investigator# 37974
Newmarket, Canada, L3Y 3R7
Site Reference ID/Investigator# 45042
Penticton, Canada, V2A 3G7
Site Reference ID/Investigator# 38428
Quispamsis, Canada, E2E 4J8
Site Reference ID/Investigator# 41487
Rimouski, Canada, G5L 8W1
Site Reference ID/Investigator# 46913
Sarnia, Canada, N7T 4X3
Site Reference ID/Investigator# 43602
Saskatoon, Canada, S7K 3H3
Site Reference ID/Investigator# 54245
St. John's, Canada, A1A 5E8
Site Reference ID/Investigator# 26922
Toronto, Canada, M5T 3L9
Site Reference ID/Investigator# 37970
Toronto, Canada, M9C 5N2
Site Reference ID/Investigator# 53383
Vancouver, Canada, V5Z 1L7
Site Reference ID/Investigator# 37964
Victoria, Canada, V8V 3P9
Site Reference ID/Investigator# 41934
Victoria, Canada, V8V 3N7
Site Reference ID/Investigator# 37971
Winnipeg, Canada, R3A 1M3
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: January 26, 2015
Health Authority: Canada: Health Canada

Keywords provided by AbbVie:
Biological Therapy
adalimumab
Rheumatoid Arthritis
Antirheumatic Agents
Anti-Inflammatory
Agents
Disease-Modifying Antirheumatic Drugs

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Adalimumab
Antirheumatic Agents
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Inflammatory Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on March 02, 2015