Study comparing the effect on disease activity when reducing or discontinuing Etanercept in subjects with Rheumatoid Arthritis (RA) (DOSERA)

Conditions: Rheumatoid Arthritis (RA) patients who are on Etanercept (ETN) treatment and are in remission or in a Low Disease Activity (LDA) state
MedDRA version: 14.0Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2007-006657-63-IS

Lead Sponsor: Pfizer Ltd., Ramsgate Road,Sandwich,Kent,CT13 9NJ,United Kingdom

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 72

Inclusion Criteria

Inclusion Criteria for the Open-label Period (Period 1):
Subject must meet all of the following conditions in order to be enrolled in the study:
1. Men and women have a diagnosis of RA based on the ACR Revised Criteria for RA.
2. Subject has a current DAS28 =3.2.
3. Subject is currently receiving treatment with sc ETN, either 25 mg BW or 50 mg QW, for a minimum of 14 months at baseline
4. Subject is currently receiving oral, sc or im MTX, 7.5 mg/week to 25 mg/week and at a stable dose for a minimum of 4 months at baseline.

Inclusion Criteria for the Double-Blind Randomized Period (Period 2)
1. Subject has completed open-label period 1 and has had DAS28 = 3.2 at all visits during period 1 and at randomization.

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 67
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

Exclusion Criteria for the Open-Label Period (Period 1)
1· Subject has earlier had an attempt of discontinuing ETN for reasons of remission or LDA state.
2. Subject has received any disease-modifying anti-rheumatic drug (DMARD), other than MTX, a dose of prednisone (or equivalent) >7.5 mg/day or has received ia, iv, im, or sc corticosteroid within one month before baseline.

Exclusion Criteria for the Double-Blind Randomized Period 2

1. Subject has used prohibited concomitant medication in period 1 or has not attended all visits in Period 1.

For additional criteria, see protocol