NCT00858780

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P25-P50 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started Jan 2009

Typical duration for phase_4 rheumatoid-arthritis

Geographic Reach
6 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 10, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

August 13, 2013

Completed
Last Updated

September 11, 2013

Status Verified

August 1, 2013

Enrollment Period

3.4 years

First QC Date

March 6, 2009

Results QC Date

June 6, 2013

Last Update Submit

August 30, 2013

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participant Who Were Non-Failures

    A participant was considered as non-failure if the calculated DAS28 \<=3.2 at all visits or if the calculated DAS28 \>3.2, the increase of calculated DAS28 from randomization (Week 0): was \<0.6 at all visit or was \>=0.6 but \<1.2 on no more than 1 consecutive visit. Percentage of participants who were non-failures calculated based on DAS28 and disease progression as determined by investigator or participant.

    Week 48

Secondary Outcomes (21)

  • Time to Treatment Failure (TTF)

    Randomization (Week 0) up to date of failure, withdrawal due to disease progression or last evaluation visit (Week 48)

  • Percentage of Participants With Remission or Low Disease Activity (LDA)

    Baseline (Week -8), Week -4, Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48

  • Percentage of Visits During Which Participants Were in Remission or Low Disease Activity State

    Randomization (Week 0) up to Week 48

  • Disease Activity Score Based on 28-Joint Count (DAS28) at Randomization

    Randomization (Week 0)

  • Change From Randomization in Disease Activity Score Based on 28-Joint Count (DAS28) at Week 6, 12, 18, 24, 30, 36, 42, and 48

    Randomization (Week 0), Week 6, 12, 18, 24, 30, 36, 42, 48

  • +16 more secondary outcomes

Study Arms (3)

1

ACTIVE COMPARATOR

50mg once weekly + methotrexate

Drug: Etanercept

2

ACTIVE COMPARATOR

25mg once weekly + methotrexate

Drug: Etanercept

3

PLACEBO COMPARATOR

once weekly + methotrexate

Drug: Placebo

Interventions

EtanerceptDRUG

50 mg etanercept once weekly + methotrexate

1
PlaceboDRUG

Placebo comparator once weekly + methotrexate

3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Pfizer Investigational Site

Glostrup Municipality, DK-2600, Denmark

Location

Pfizer Investigational Site

Hellerup, 2900, Denmark

Location

Pfizer Investigational Site

Jyväskylä, Finland, 40620, Finland

Location

Pfizer Investigational Site

Helsinki, FI-00029 HUS, Finland

Location

Pfizer Investigational Site

Gyula, 5701, Hungary

Location

Pfizer Investigational Site

Szombathely, 9700, Hungary

Location

Pfizer Investigational Site

Veszprém, 8200, Hungary

Location

Pfizer Investigational Site

Reykjavik, 108, Iceland

Location

Pfizer Investigational Site

Bergen, 5021, Norway

Location

Pfizer Investigational Site

Lillehammer, 2609, Norway

Location

Pfizer Investigational Site

Oslo, 0319, Norway

Location

Pfizer Investigational Site

Lund, 221 85, Sweden

Location

Pfizer Investigational Site

Malmo, SE-205 02, Sweden

Location

Pfizer Investigational Site

Stockholm, 14186, Sweden

Location

Pfizer Investigational Site

Stockholm, 17176, Sweden

Location

Pfizer Investigational Site

Uppsala, 751 85, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 25873634DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Etanercept

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane Proteins

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 6, 2009

First Posted

March 10, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 11, 2013

Results First Posted

August 13, 2013

Record last verified: 2013-08

Locations

IC(1)HU(3)FI(2)DK(2)NO(3)SE(5)