NCT00524381

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2007

Geographic Reach
1 country

1 active site

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

August 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

August 30, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2007

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

February 23, 2010

Status Verified

February 1, 2010

Enrollment Period

1.9 years

First QC Date

August 30, 2007

Last Update Submit

February 22, 2010

Conditions

Polymyalgia Rheumatica

Outcome Measures

Primary Outcomes (1)

  • Polymyalgia rheumatica activity score (PMR-AS)

    14 days

Secondary Outcomes (3)

  • Plasma concentrations of various cytokines, chemokines, and adipokines

    14 days

  • Quantitative use of analgesics

    14 days

  • Insulin sensitivity (HOMA)

    14 days

Interventions

Etanercept (Enbrel)DRUG

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

Sodium chloride (placebo)DRUG

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

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Persons with active polymyalgia rheumatica (patients only).
  • Signed informed consent and written authorization.

You may not qualify if:

  • Other inflammatory conditions than polymyalgia rheumatica, including symptoms of giant cell arteritis, e.g. head aches, jaw claudication and visual disturbances.
  • Current malignancy or history of malignancy.
  • Neuromuscular conditions.
  • Infections with systemic impact.
  • Uncontrolled diabetes mellitus.
  • Uncontrolled hypertension.
  • Current tuberculosis or history of tuberculosis.
  • Severe heart failure (NYHA class 3 and 4).
  • Current use of glucocorticoids, biological drugs, and immunosuppressive drugs.
  • Polymyalgia rheumatica.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bispebjerg Hospital, Department of Rheumatology

Copenhagen NV, DK-2400, Denmark

Location

Related Publications (2)

  • Kreiner FF, Galbo H. Activity of the neuroendocrine axes in patients with polymyalgia rheumatica before and after TNF-alpha blocking etanercept treatment. Arthritis Res Ther. 2012 Aug 15;14(4):R186. doi: 10.1186/ar4017.

    PMID: 22894827DERIVED

  • Kreiner F, Galbo H. Effect of etanercept in polymyalgia rheumatica: a randomized controlled trial. Arthritis Res Ther. 2010;12(5):R176. doi: 10.1186/ar3140. Epub 2010 Sep 20.

    PMID: 20854662DERIVED

MeSH Terms

Conditions

Polymyalgia Rheumatica

Interventions

EtanerceptSodium Chloride

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsImmunoglobulin Constant RegionsImmunoglobulinsImmunoproteinsBlood ProteinsProteinsSerum GlobulinsGlobulinsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane ProteinsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Henrik Galbo, Professor

    Bispebjerg Hospital, Department of Rheumatology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2007

First Posted

September 3, 2007

Study Start

August 1, 2007

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

February 23, 2010

Record last verified: 2010-02

Locations

DK(1)