T cells and TNF: The impct of TNF blockade on effector T cell populations in rheumatoid arthritis and other conditions treated with anti-TNF-alpha agents. - T cells and TNF

Phase 1

• Conditions: Rheumatoid arthritis Psoriatic arthritis Ankylosing spondylitis; MedDRA version: 12.0 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis; MedDRA version: 12.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis; MedDRA version: 12.0 Level: LLT Classification code 10002556 Term: Ankylosing spondylitis

• Registration Number: EUCTR2009-012424-87-GB
• Lead Sponsor: Imperial College London South Kensington London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-10-14
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 55

Inclusion Criteria

- Anti-TNF naive patients
- Patients due to start treatment with anti-TNF blocking drugs - etanercept or adalimumab
- Patients with rheumatoid arthritis should meet the 1987 American College of Rheumatology (ACR) revised classification criteria, should have active rheumatoid arthritis as defined by a DAS28 score >5.1 and should be on a stable dose of disease-modifying drugs for the previous 1 month and a stable dose of glucocorticoids for at least 4 weeks prior to study entry.
-Patients with psoriatic arthritis should have a secure diagnosis confirmed by a rheumatologist and concurrent psoriatic skin lesions. If on disease-modifying therapy, patients should be on a stable dose for the the previous 1 month prior to study entry.
-Patients with ankylosing spondylitis should fulfill the Modified New York Criteria for diagnosis of ankylosing spondylitis and if taking disease-modifying therapy, they should be on a stable dose for the previous 1 month prior to study entry.
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

- Patients who have been previously treated with anti-TNF therapy for whatever reason
- Patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis who do not fulfill the diagnostic criteria for these conditions as above.
- Patients who have received an intra-articular injection of steroids or have received an intramuscular injection of depot steroid to treat disease flare in the preceding 4 weeks prior to commencing anti-TNF therapy.
- Patients with intercurrent, active infection of any type, excluding the common cold.

Study & Design

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