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Etanercept Treatment in the Early Course of Polymyalgia Rheumatica

NCT00524381 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-02-23

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effect of the tumor necrosis factor alpha (TNF) antagonist, etanercept, on the early clinical course of polymyalgia rheumatica (PMR).

PMR is a common inflammatory disease with an unknown etiology that is characterized by aching, tender, and stiff proximal muscle. Some evidence suggests that TNF plays a central role in the pathophysiology of PMR.

The preferred treatment with glucocorticoids (GCs) is adequate for most patients, but a subset of patients have a more prolonged, relapsing disease course. These patients require treatment with GCs for 1 to 2 years. GC related adverse events are frequent during treatment.

Conditions

  • Polymyalgia Rheumatica

Interventions

DRUG

Etanercept (Enbrel)

TNF-alpha antagonist, subcutaneous injection, 25 mg twice/week, 14 days.

DRUG

Sodium chloride (placebo)

NaCl, isotonic saline, subcutaneous injection, 1 ml twice/week, 14 days.

Sponsors & Collaborators

  • Bispebjerg Hospital

    lead OTHER

Principal Investigators

  • Henrik Galbo, Professor · Bispebjerg Hospital, Department of Rheumatology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2009-07-31
Completion
2009-09-30

Countries

  • Denmark

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00524381 on ClinicalTrials.gov