Etanercept Treatment in the Early Course of Polymyalgia Rheumatica

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00524381
Study type	Interventional
Source	Bispebjerg Hospital
Contact
Status	Completed
Phase	Phase 3
Start date	August 2007
Completion date	September 2009

View Details

See also
Status	Clinical Trial	Phase
Terminated	`NCT04972968` - A Study to Evaluate the Change in Disease State and Adverse Events in Adult Participants With Polymyalgia Rheumatica (PMR) Dependent on Glucocorticoid Treatment, Receiving Subcutaneous Injections of ABBV-154	Phase 2
Active, not recruiting	`NCT04519580` - Improved Diagnostics and Monitoring of Polymyalgia Rheumatica
Recruiting	`NCT06460142` - Assessing Biomarker in Giant Cell Arteritis and Polymyalgia Rheumatic
Terminated	`NCT03600818` - Evaluation of the Efficacy and Safety of Sarilumab in Patients With Polymyalgia Rheumatica	Phase 3
Completed	`NCT00836810` - Timed Release Tablet Prednisone in Polymyalgia Rheumatica	Phase 2/Phase 3
Completed	`NCT04239521` - The Epidemiology, Management, and the Associated Burden of Related Conditions in Alopecia Areata
Completed	`NCT03263715` - A Study to Evaluate the Efficacy of Tocilizumab as a Remission-Induction and Glucocorticoid-Sparing Regimen in Subjects With New-Onset Polymyalgia Rheumatica (PMR- SPARE)	Phase 3
Recruiting	`NCT05935709` - DANIsh VASculitis Database (DANIVAS)
Not yet recruiting	`NCT02985424` - Polymyalgia Rheumatica and Giant Cell Arteritis	N/A
Completed	`NCT00138983` - Prevention of Glucocorticoid-Induced Osteoporosis in Rheumatic Diseases: Alendronate Versus Alfacalcidol.	Phase 3
Recruiting	`NCT06130540` - Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Intravenous Secukinumab in Patients With GCA or PMR	Phase 1
Recruiting	`NCT05767034` - Phase III Study of Efficacy and Safety of Secukinumab Versus Placebo, in Combination With Glucocorticoid Taper Regimen, in Patients With Polymyalgia Rheumatica (PMR)	Phase 3
Terminated	`NCT01821040` - A Study Assessing the Efficacy and Safety of Lodotra® Compared to Prednisone IR in Subjects Suffering From PMR	Phase 3
Recruiting	`NCT00982332` - Efficacy of Micro-Pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica	N/A
Recruiting	`NCT05312944` - Polymyalgia Rheumatica Associated to Primary Sjogren Syndrome
Recruiting	`NCT04664465` - PRediction Of DIverse Glucocorticoids toxIcity OUtcomeS
Withdrawn	`NCT02899026` - Efficacy and Safety Study of Sirukumab in Subjects With Polymyalgia Rheumatica	Phase 3
Recruiting	`NCT03576794` - Treatment With Leflunomide in Patients With Polymyalgia Rheumatica	Phase 3
Completed	`NCT05681676` - Melanocortin Gene Expression in Lymphocytes of Polymyalgia Patients
Recruiting	`NCT05435781` - Effect of Supplemental Hydrocortisone During Stress in Prednisolone-induced Adrenal Insufficiency	Phase 4