Clinical trial NCT00858780: Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA
Official title: Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2009-03-10
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study involves Rheumatoid Arthritis patients in regular clinical setting who are already on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is intended to identify parameters that can serve as guidance in clinical settings. This study will consider the clinical and radiographic course in subjects when etanercept treatment is tapered or discontinued, and analyze the subjects' experience of disease worsening and the predictive values of clinical parameters, serum biomarkers and imaging on the clinical and radiographic course in different treatment groups. The effect of re-treatment with etanercept at treatment failure will also be studied.


Eligibility 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:

* 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.

Primary outcomes:
measure: Percentage of Participant Who Were Non-Failures
timeFrame: Week 48
Secondary outcomes:
measure: Time to Treatment Failure (TTF)
timeFrame: Randomization (Week 0) up to date of failure, withdrawal due to disease progression or last evaluation visit (Week 48)
measure: Percentage of Participants With Remission or Low Disease Activity (LDA)
timeFrame: Baseline (Week -8), Week -4, Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
measure: Percentage of Visits During Which Participants Were in Remission or Low Disease Activity State
timeFrame: Randomization (Week 0) up to Week 48
measure: Disease Activity Score Based on 28-Joint Count (DAS28) at Randomization
timeFrame: Randomization (Week 0)
measure: Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48
timeFrame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
measure: Change From Randomization in Tender Joints Count (TJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
timeFrame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
measure: Change From Randomization in Swollen Joints Count (SJC) at Week 6, 12, 18, 24, 30, 36, 42, and 48
timeFrame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
measure: Change From Randomization in Physician Global Assessment (PGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
timeFrame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
measure: Change From Randomization in Participant Global Assessment (PtGA) of Disease Activity at Week 6, 12, 18, 24, 30, 36, 42, and 48
timeFrame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
measure: Participant General Health Visual Analog Scale (VAS) at Randomization
timeFrame: Randomization (Week 0)
measure: Change From Randomization in Participant General Health Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
timeFrame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
measure: Participant Pain Visual Analog Scale (VAS) at Randomization
timeFrame: Randomization (Week 0)
measure: Change From Randomization in Participant Pain Visual Analog Scale (VAS) at Week 6, 12, 18, 24, 30, 36, 42, and 48
timeFrame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
measure: Change From Randomization in Morning Stiffness Duration at Week 6, 12, 18, 24, 30, 36, 42, and 48
timeFrame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
measure: Change From Randomization in Erythrocyte Sedimentation Rate (ESR) at Week 6, 12, 18, 24, 30, 36, 42, and 48
timeFrame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
measure: Change From Randomization in C-Reactive Protein (CRP) Level at Week 6, 12, 18, 24, 30, 36, 42, and 48
timeFrame: Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48
measure: Change From Randomization in Modified Total Sharp Score (mTSS) at Week 48
timeFrame: Randomization (Week 0), Week 48
measure: Magnetic Resonance Imaging (MRI) Findings at Randomization
timeFrame: Randomization (Week 0)
measure: Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (S-Score) at Week 12
timeFrame: Randomization (Week 0), Week 12
measure: Change From Randomization in Magnetic Resonance Imaging (MRI) Findings (O-Score, E-Score) at Week 12
timeFrame: Randomization (Week 0), Week 12
measure: Percentage of Participants in Treatment Failure for Each Potentially Predictor Variable at Randomization
timeFrame: Randomization (Week 0) up to Week 48
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Pfizer Investigational Site
city: Hellerup
country: Denmark
facility: Pfizer Investigational Site
city: Helsinki
country: Finland
facility: Pfizer Investigational Site
city: Jyvaskyla
country: Finland
facility: Pfizer Investigational Site
city: Gyula
country: Hungary
facility: Pfizer Investigational Site
city: Szombathely
country: Hungary
facility: Pfizer Investigational Site
city: Veszprem
country: Hungary
facility: Pfizer Investigational Site
city: Reykjavik
country: Iceland
facility: Pfizer Investigational Site
city: Bergen
country: Norway
facility: Pfizer Investigational Site
city: Lillehammer
country: Norway
facility: Pfizer Investigational Site
city: Oslo
country: Norway
facility: Pfizer Investigational Site
city: Lund
country: Sweden
facility: Pfizer Investigational Site
city: Malmo
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Uppsala
country: Sweden
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: van Vollenhoven RF, Ostergaard M, Leirisalo-Repo M, Uhlig T, Jansson M, Larsson E, Brock F, Franck-Larsson K. Full dose, reduced dose or discontinuation of etanercept in rheumatoid arthritis. Ann Rheum Dis. 2016 Jan;75(1):52-8. doi: 10.1136/annrheumdis-2014-205726. Epub 2015 Apr 14.