To see whether for patients with established rheumatoid arthritis that have already achieved a good response to Tumour Necrosis Factor Inhibitor (TNF inhibitor) treatment, whether the treatment be tapered to a minimum dose without affecting the control of disease activity.

Phase 1

• Conditions: Patients with established Rheumatoid arthritis; MedDRA version: 14.0 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2010-020738-24-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-17
• Study Completion: 2014-07-07
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 97

Inclusion Criteria

a.RA by the criteria of the American College of Rheumatology
b.Etanercept or adalimumab treatment for at least 6 months (a break of up to 4 consecutive weeks is permitted).
c.Taking at least one DMARD from the list in the study protocol
d.Stable clinical response for at least 3 months (one DAS28 score of at least 3.2; no changes in DAS28 >0.6 in the last 3 months)
e.Patient considers he or she has achieved a suitable response to TNF inhibitors
f.Supervising rheumatologist considers further improvements are unlikely on the patient’s current treatment regimen.
g.At least 18 years of age
h.Willing and able to give informed consent

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 99
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 99

Exclusion Criteria

a.Serious concurrent illness (e.g. terminal cancer)
b.Prednisolone at more than 10mg daily (for doses > 10mg daily, a 4 week washout period is required)
c.Recently received IM/IA steroids (4 weeks washout required)
d.Participation in another clinical trial (other than observational or lifestyle studies and registries) concurrently or within 12 weeks of screening
e.Pregnancy, breast-feeding or women of child-bearing potential not using adequate contraception

Study & Design

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