NCT00161655

CompletedPhase 4

Study Evaluating Etanercept and Methotrexate in Plaque Psori...

Wyeth is now a wholly owned subsidiary of Pfizer Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

0881A-101696

Study Type

interventional

Reported enrollment (type unavailable)

60

Locations

4 countries

Sites

8

Timeline

Study Start

April 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2006

Actual (reported)

Study Completion

December 2006

Actual (reported)

Brief Summary

The purpose of this study is to evaluate the efficacy to clear or almost clear the plaques in plaque psoriasis patients, treated with the combination etanercept and methotrexate compared to etanercept alone.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 60 participants
Study completion date: December 2006
Actual (reported)
Listed locations: 4 countries · 8 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
April 2005
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 8, 2005
Actual (reported)
First Posted
September 12, 2005
Actual (reported)
Primary Completion
August 2006
Actual (reported)
Study Completion
December 2006
Actual (reported)

Last Updated: September 28, 2009
Status Verified: September 2009
Last Update Submitted: September 25, 2009

Conditions

Arthritis, Psoriatic Psoriasis

Keywords

PsoriasisArthritis

Outcome Measures

Primary Outcomes (1)

Proportion of pts whose plaque psoriasis is cleared or almost cleared after 24 weeks.

Secondary Outcomes (2)

Percentage improvement in PASI. Proportion of pts demonstrating PASI 50, 75
and 90. Time to clear or almost clear on PGA.

Interventions

EtanerceptDrug

MethotrexateDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Active plaque psoriasis involving \>10% body surface area and/or minimal screening PASI score 8.
Methotrexate \>7.5 mg/week for the last 3 months

You may not qualify if:

Sponsors & Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer
Industrylead

Study Sites (8)

Fredriksberg Alle, Copenhagen, Denmark

Gentofte Amtsygehus, Hellerup, Denmark

Helsinki, Helsinki, Finland

Tampere, Pirkanmaa, Finland

Rikshospitalet, Olso, Norway

Hudlegekontoret Akutten, Tromso, Norway

Lakarhuset Fasta Centrum, Farsta, Sweden

MeSH Terms

Conditions

PsoriasisArthritis, PsoriaticArthritis

Interventions

EtanerceptMethotrexate

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue DiseasesSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
STUDY DIRECTOR

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: NONE
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

April 2005

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

August 2006

Actual (reported)

NCT00195494

Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis

Phase 4Completed

NCT00332332

Canadian Assessment of Patient Outcomes and Effectiveness of Etanercept (Enbrel) in Psoriasis

Phase 4Completed

NCT00581555

Evaluation of Etanercept in Patients With Plaque Psoriasis After Stopping Ciclosporin Therapy

Phase 4Completed

NCT00127842

REPArE: Rating Evaluations in Psoriatic Arthritis (PsA) With Etanercept (Enbrel®)

Phase 4Completed

NCT00967538

Safety and Efficacy of Etanercept in Patients With Psoriasis Who Failed to Respond to Other Biologic Treatments

Phase 4Completed

NCT01187264

Dose Ranging Study to Compare the Efficacy and Safety of Methotrexate in Plaque Type Psoriasis

Phase 4Completed

Predominantly guttate, erythrodermic or pustular psoriasis
Other skin conditions than psoriasis

Contact the study team to confirm eligibility.

Lakarhuset, Vallingby, Sweden

Joint Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane ProteinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Completion

December 2006

Actual (reported)

Last Updated

September 28, 2009

Record last verified: 2009-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00161655
Data provider: ClinicalTrials.gov
Source updated: 2009-09-28
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:28 UTC

Locations

DK(2)FI(2)NO(2)SE(2)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations