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

Last updated on December 17, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Glostrup, , DK-2600 Denmark
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00858780
Pfizer
Completed
Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA

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Study Comparing The Effect On Disease Activity When Reducing Or Discontinuing Etanercept In Subjects With RA
Dose Reduction or Discontinuation of Etanercept in Methotrexate-Treated Rheumatoid Arthritis Subjects Who Have Achieved a Stable Low Disease Activity-state (DOSERA)
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: Etanercept
    50 mg etanercept once weekly + methotrexate
  • Drug: Etanercept
    25mg etanercept once weekly + methotrexate
  • Drug: Placebo
    Placebo comparator once weekly + methotrexate
  • Active Comparator: 1
    50mg once weekly + methotrexate
    Intervention: Drug: Etanercept
  • Active Comparator: 2
    25mg once weekly + methotrexate
    Intervention: Drug: Etanercept
  • Placebo Comparator: 3
    once weekly + methotrexate
    Intervention: Drug: Placebo
van Vollenhoven RF, Østergaard 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.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
91
June 2012
June 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Finland,   Hungary,   Iceland,   Norway,   Sweden
 
 
NCT00858780
0881K1-4500
B1801016
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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