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

NCT01162421 | Completed Phase 4 Results

• 1 other identifier: W12-122
• Study Type: interventional
• Target: 77
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With No Radiographic Progression at Month 12

  Radiographic progression was defined as change from Baseline in the modified Total Sharp Score (mTSS) of ≤ 0.5 units). The mTSS is a measure of change in joint health: digitized images of radiographs of hands and feet obtained at Screening and Month 12 were scored in a blinded manner. Joints were scored for erosions on a scale from 0 (no damage) to 5 (complete collapse) and joint space narrowing on a scale from 0 (no damage) to 4 (ankylosis or complete dislocation). Erosion scores and narrowing scores were added to obtain the mTSS (range = 0 \[normal\] to 398 \[maximal disease\]). An increase in mTSS from Baseline represents disease progression and/or joint worsening, no change represents halting of disease progression, and a decrease represents improvement.

  Baseline, Month 12

Secondary Outcomes (36)

• Percentage of Participants With No Radiographic Progression at Month 6 and Month 24

  Baseline, Month 6, Month 24

• Change From Baseline in mTSS at Months 6, 12 and 24

  Baseline, Month 6, Month 12, Month 24

• Percentage of Participants With Rapid Radiographic Progression at Month 12

  Month 12

• Percentage of Participants With American College of Rheumatology 20% (ACR20) Response at Months 3, 6, 9, 12, 18 and 24

  Baseline, Months 3, 6, 9, 12, 18, 24

• Percentage of Participants With American College of Rheumatology 50% (ACR50) Response at Months 3, 6, 9, 12, 18 and 24

  Baseline, Months 3, 6, 9, 12, 18, 24

Study Arms (2)

Early Adalimumab

EXPERIMENTAL

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

Biological: adalimumab; Drug: Methotrexate

Standard of Care

ACTIVE COMPARATOR

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.

Biological: adalimumab; Drug: Methotrexate

Interventions

adalimumab 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.

Also known as: ABT-D2E7, Humira

Early Adalimumab; Standard of Care

Methotrexate DRUG

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

Also known as: Trexall, Rheumatrex

Early Adalimumab; Standard of Care

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \>/= 20 mm/1h or C-reactive protein \> upper limit of normal.
• 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.

You may not qualify if:

• Subject has previous exposure to any biologic therapy including adalimumab.
• Prior disease-modifying antirheumatic drugs 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead
• Mount Sinai Hospital, Canada: collaborator

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab; Methotrexate

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Global Medical Information
• Organization: AbbVie

800-633-9110

Study Officials

• Christina Pelizon, MD

  AbbVie Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2010
• First Posted: July 14, 2010
• Study Start: September 1, 2010
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 1, 2016
• Results First Posted: November 1, 2016

Record last verified: 2016-09