Infliximab Therapy in Patients With Refractory Polymyalgia Rheumatica
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Infliximab Therapy in Patients With Refractory Polymyalgia Rheumatica: a Double Blind Placebo Controlled Trial|
- Proportion of responders(complete remission without corticosteroids) [ Time Frame: at 24 weeks ] [ Designated as safety issue: Yes ]
- Proportion of responders [ Time Frame: at 48 weeks ] [ Designated as safety issue: Yes ]
- Time to response [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
- Number of relapses / recurrences [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Response duration [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Cumulative dose and side effects of steroids [ Time Frame: at 24 and 48 weeks ] [ Designated as safety issue: Yes ]
- Number of patients that should be re-treated with infliximab [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
- Side effects of Infliximab in this patient population [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||June 2007|
|Estimated Study Completion Date:||December 2011|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Infliximab 5 mg/kg. i.v. at week 0, 2, 6, 14 y 22.
Other Name: Remicade, anti-TNF monoclonal Therapy
|Placebo Comparator: inactive powder||
Drug: inactive powder
Inactive powder. i.v. at week 0, 2, 6, 14 y 22.
Other Name: placebo
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|Reumatology division, Hospital Universitario Marques de Valdecilla|
|Santander, Cantabria, Spain, 39008|
|Study Director:||Víctor M Martínez-Taboada,, Md, PhD||Servicio de Reumatología, Hospital Universitario Marques de Valdecilla|
|Principal Investigator:||Vicente Rodriguez-Valverde, MD, PhD||Servicio de Reumatología, Hospital Universitario Marques de Valdecilla|