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Infliximab Therapy in Patients With Refractory Polymyalgia Rheumatica

NCT01423591 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2011-08-26

No results posted yet for this study

Summary

Rheumatic Polymyalgia(PMR) is a relatively common chronic inflammatory disorder of unknown origin which predominantly develops in elderly subjects and presents with severe pain and stiffness in the neck, shoulder and pelvic girdles, along with increased acute phase reactants. Systemic manifestations such as fever, anorexia and weight loss are characteristic signatures of PMR.

Corticosteroids (CS) constitute the standard treatment of PMR. Although in most patients the symptoms of the disease disappear after one or two years of treatment, a proportion of patients remain CS-dependent with the subsequent CS toxicity. Open label studies have suggested that tumour necrosis factor (TNF) antagonists lead to sustained improvement and CS sparing effect in patients with refractory PMR.

The investigators conducted a randomised, double-blind, placebo controlled trial with infliximab in CS-dependent patients with PMR. Patients with CS-dependent PMR (defined as requiring ≥ 5 mg/day after at least 2 years of treatment to maintain remission or ≥ 7.5 mg/day after at least 6 months) were randomly assigned to receive Infliximab (5 mg/kg i.v) at 0, 2, 6, 14 and 22 weeks (n = 12) or placebo (n = 11) together with CS that were reduced according to a predefined schedule. The primary outcome was the proportion of responder patients -defined as individuals with both complete clinical and analytical remission without receiving CS for at least three months- at 24 weeks. Secondary outcomes were cumulative CS doses and adverse events proportion.

Conditions

  • Polymyalgia Rheumatica

Interventions

DRUG

infliximab

Infliximab 5 mg/kg. i.v. at week 0, 2, 6, 14 y 22.

DRUG

inactive powder

Inactive powder. i.v. at week 0, 2, 6, 14 y 22.

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • Hospital Universitario Marqués de Valdecilla

    lead OTHER

Principal Investigators

  • Víctor M Martínez-Taboada,, Md, PhD · Servicio de Reumatología, Hospital Universitario Marques de Valdecilla

  • Vicente Rodriguez-Valverde, MD, PhD · Servicio de Reumatología, Hospital Universitario Marques de Valdecilla

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-09-30
Completion
2011-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Drugs

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 NCT01423591 on ClinicalTrials.gov