Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00858780
• Date of registration: 06/03/2009
• Primary sponsor: Pfizer
• Public title: Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA DOSERA
• Scientific title: Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA)
• Date of first enrolment: January 2009
• Target sample size: 72
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00858780
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Denmark, Finland, Hungary, Iceland, Norway, Sweden

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

Inclusion criteria:

- Subject has a current DAS28 equal to or less than 3.2.

- Subject is currently receiving treatment with etanercept, either 25 mg twice weekly
or 50 mg once weekly, for a minimum of 14 months at baseline

- Subject is currently receiving oral, sc or intramuscular methotrexate once weekly,
7.5 mg/week to 25 mg/week and at a stable dose for a minimum of 4 months at baseline.

Exclusion Criteria:

Exclusion criteria:

- Subject has earlier had an attempt of discontinuing etanercept for reasons of
remission or low disease activity state.

- Subject has received any disease-modifying anti-rheumatic drug, other than
methotrexate, within one month before baseline.

- Subject has had a dose of prednisone (or equivalent) >7.5 mg/day or has received
intra-articular, intravenous, intramuscular, or subcutaneous corticosteroid within
one month of baseline.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Drug: Etanercept

Drug: Placebo

Primary Outcome(s)

Proportion of subjects who are non-failures (still in Period 2) at week 48. [Time Frame: 48 weeks]

Secondary Outcome(s)

Change in DAS28 at each visit. [Time Frame: 48 weeks]

Change in MRI findings at week 12. [Time Frame: 12 weeks]

Change in mTSS at week 48. [Time Frame: 48 weeks]

Change in physician global assessments, subject global assessments, patient global health VAS, patient pain VAS and morning stiffness at each visit. [Time Frame: 48 weeks]

Change in tender and swollen joint counts at each visit. [Time Frame: 48 weeks]

Changes in ESR and CRP at each visit. [Time Frame: 48 weeks]

Correlation between clinical assessment, serum biomarkers, MRI (at randomization and week 12) and X-ray findings at randomization and whether individuals have had treatment failure or not. [Time Frame: 48 weeks]

Proportion of subjects in remission or LDA state at each visit. [Time Frame: 48 weeks]

Proportion of time subjects are in remission or LDA state [Time Frame: 48 weeks]

Time from randomization to failure, according to predefined criteria. [Time Frame: 48 weeks]

Secondary ID(s)

0881K1-4500

B1801016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors