You are about to leave an AbbVie Canada site, a Web site maintained by AbbVie Corporation.

This link is provided for your convenience only. AbbVie Corporation takes no responsibility for the content of any Web site maintained by any third party and makes no representation as to the accuracy or completeness of any information contained on this or any subsequent link.

Do you wish to leave this site?

Yes No

You are here

RADAR

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

    Status Completed
    Related Conditions
    Rheumatoid Arthritis

Enrollment Details

Phases: 

  • 1
  • 2
  • 3
  • 4
Study Type:  Interventional

This is a type IV phase trial.

Protocol ID
W12-122

Brief summary

Top

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.

Participant Attributes :
  • Male and Female
  • Ages 18 Years and older

Canada: 32

0
Brampton, ON
1
Burlington, ON
2
Calgary, AB
3
Edmonton, AB
4
Kelowna, BC
5
Mississauga, ON
6
Westmount, QC
7
Newmarket, ON
8
Ottawa, ON
9
Penticton, BC
10
Quispamsis, NB
11
Saint-Jérôme, QC
12
Saskatoon, SK
13
Saint-Eustache, QC
14
Vancouver, BC
15
Victoria, BC
16
Halifax, NS
17
Hamilton, ON
18
Hamilton, ON
19
Montreal, QC
20
Rimouski, QC
21
St. John's, NL
22
Toronto, ON
23
Victoria, BC
24
Winnipeg, MB
25
Charlottetown, PE
26
Ottawa, ON
27
Pointe-Claire, QC
28
Sarnia, ON
29
Sherbrooke, QC
30
St. John's, NL
31
Toronto, ON
Would you like to know more about this trial?

Study Design

  • The method used to assign participants to an arm of a clinical trial, for example Randomized (assigned by chance) versus Non-randomized.
    ?

    Allocation

    Randomized

  • A target outcome that the study’s protocol aims to evaluate - things like: the occurrence of a disease, a symptom, sign, or lab abnormality, among others.
    ?

    Endpoint Classification

    Efficacy Study

  • The general design that shows how the medical interventions will be assigned to the participants, e.g., whether all patients will receive the same drug, or if different groups receive two or more different treatments in a particular order.
    ?

    Intervention Model

    Parallel Assignment

  • The general design that describes the strategy for identifying and following up with participants during observational studies.
    ?

    Masking

    Open Label

  • This is the single main reason for carrying out the clinical trial. Reasons can include: treatment, prevention, diagnostic advances, supportive care, screening, or health services research, among others.
    ?

    Purpose

    Treatment

    • 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):
    • Subject must fulfill at least one of the following three 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.

More on this trial

Clinical Trials.gov