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

NCT ID: NCT00858780

Last Updated: 2013-09-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

50mg once weekly + methotrexate

Group Type ACTIVE_COMPARATOR

Etanercept

Intervention Type DRUG

50 mg etanercept once weekly + methotrexate

2

25mg once weekly + methotrexate

Group Type ACTIVE_COMPARATOR

Etanercept

Intervention Type DRUG

25mg etanercept once weekly + methotrexate

3

once weekly + methotrexate

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo comparator once weekly + methotrexate

Interventions

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Etanercept

50 mg etanercept once weekly + methotrexate

Intervention Type DRUG

Etanercept

25mg etanercept once weekly + methotrexate

Intervention Type DRUG

Placebo

Placebo comparator once weekly + methotrexate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Glostrup Municipality, , Denmark

Site Status

Pfizer Investigational Site

Hellerup, , Denmark

Site Status

Pfizer Investigational Site

Jyväskylä, Finland, Finland

Site Status

Pfizer Investigational Site

Helsinki, , Finland

Site Status

Pfizer Investigational Site

Gyula, , Hungary

Site Status

Pfizer Investigational Site

Szombathely, , Hungary

Site Status

Pfizer Investigational Site

Veszprém, , Hungary

Site Status

Pfizer Investigational Site

Reykjavik, , Iceland

Site Status

Pfizer Investigational Site

Bergen, , Norway

Site Status

Pfizer Investigational Site

Lillehammer, , Norway

Site Status

Pfizer Investigational Site

Oslo, , Norway

Site Status

Pfizer Investigational Site

Lund, , Sweden

Site Status

Pfizer Investigational Site

Malmo, , Sweden

Site Status

Pfizer Investigational Site

Stockholm, , Sweden

Site Status

Pfizer Investigational Site

Stockholm, , Sweden

Site Status

Pfizer Investigational Site

Uppsala, , Sweden

Site Status

Countries

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Denmark Finland Hungary Iceland Norway Sweden

References

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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.

Reference Type DERIVED
PMID: 25873634 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=0881K1-4500&StudyName=Study%20Comparing%20The%20Effect%20On%20Disease%20Activity%20When%20Reducing%20Or%20Discontinuing%20Etanercept%20In%20Subjects%20With%20RA

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Other Identifiers

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B1801016

Identifier Type: -

Identifier Source: secondary_id

0881K1-4500

Identifier Type: -

Identifier Source: org_study_id