A Randomised, Pragmatic, Open-label study of Adalimumab versus Etanercept for Rheumatoid Arthritis. - Adalimumab versus Etanercept for RA

Phase 1

• Conditions: Rheumatoid Arthritis; MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders

• Registration Number: EUCTR2006-006275-21-GB
• Lead Sponsor: niversity Hospital Birmingham NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2011-06-30
• Study Start: 2011-10-18
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 124

Inclusion Criteria

1. Men and women over the age of 18 years with rheumatoid arthritis meeting international disease classification criteria.
2. NICE Criteria for treatment with TNF inhibitors in regard to lack of response to at least two DMARDs (one of which must be methotrexate at adequate doses and for a defined period of time - according to NICE criteria).
3. Willing to enter study and able to understand the procedures and comply with the study protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Any condition(s) which, in the opinion of the physician caring for the patient, makes that patient unsuitable for a TNF inhibitor for their arthritis.

2. Any individual unable to understand study procedures or unwilling to comply.

3. Previous treatment with any licensed or experimental biological TNF inhibitor.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the proportions of people still taking adalimumab or etanercept one year after starting treatment for rheumatoid arthritis. Our objective is to determine whether adalimumab is inferior to etanercept for the treatment of rheumatoid arthritis.;Secondary Objective: To measure, by routine clinical procedures and by questionnaires: whether the two drugs are equally beneficial for rheumatoid arthritis; whether side effects,adverse reactions and reasons for discontinuing treatment are similar; and whether patients taking the drugs are equally satisifed with their medication. ;Primary end point(s): The proportions of patients still taking adalimumab and etanercept one year after starting treatment. Patients will be deemed to be still on treatment if an injection of adalimumab or etanercept has been used 12 months after starting therapy, with a window of 2 weeks either side of the 12 month anniversary.