Infliximab Therapy in Patients With Refractory Polymyalgia Rheumatica
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Polymyalgia Rheumatica |
Drug: infliximab Drug: inactive powder |
Phase 3 |
| Study Type: | Interventional |
| 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 ]
| Enrollment: | 23 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | December 2011 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: infliximab |
Drug: infliximab
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- PMR patients that after 2 years of corticosteroid treatment are not able to reduce the dose of prednisone below 5 mg/day or equivalent.
- PMR patients that after 6 months of corticosteroid treatment are not able to reduce the dose of prednisone below 7,5 mg/day or equivalent.
PMR patients should fulfill the criteria proposed by Chuang et al (8):
- Age ≥ of 50 years.
- Development of bilateral moderately/severe aching and stiffness persisting for 1 month or more, involving two of the following areas: neck or torso, shoulders or proximal regions of the arms, and hips or proximal aspects of the thighs.
- ESR ≥ 40 mm/h.
- Complete clinical response to low-dose of steroids (prednisone or equivalent ≤ 20mg/day)
Exclusion Criteria:
- -Patients with biopsy-proven GCA or those with cranial symptoms or signs suggestive of GCA but without biopsy-proven arteritis.
- Patients with clinical features suggestive of RA or other connective tissue disorders.
- Chronic infections such as HIV, hepatitis B or C, active mycobacterial or fungal infections, etc.
- Neoplasm or a history of malignancy in the preceding 5 years.
- Patients with multiple sclerosis or other demilinizating disorders.
- Patients with cytopenias: leukopenia (leukocytes ≤ 3.5x109/L.), thrombocytopenia (platelets ≤ 100x109/L.) and/or anemia (≤ 10 g./dl.)
- Patients with cardiac failure (functional class III / IV).
- Any other condition that contraindicates Infliximab therapy
Contacts and Locations| Spain | |
| 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 |
More Information
No publications provided
| Responsible Party: | Dr. Vicente Rodri-guez Valverde, Rheumatology, MD, PhD, Hospital Universitario Marqués de Valdecilla |
| ClinicalTrials.gov Identifier: | NCT01423591 History of Changes |
| Other Study ID Numbers: | P04578 |
| Study First Received: | July 19, 2011 |
| Last Updated: | August 25, 2011 |
| Health Authority: | Spain: Agencia Española de Medicamentos y Productos Sanitarios |
Keywords provided by Hospital Universitario Marqués de Valdecilla:
|
Infliximab polymyalgia rheumatica refractory |
double blind placebo controlled trial |
Additional relevant MeSH terms:
|
Polymyalgia Rheumatica Giant Cell Arteritis Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Connective Tissue Diseases Vasculitis, Central Nervous System Autoimmune Diseases of the Nervous System Nervous System Diseases Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Arteritis Vascular Diseases |
Cardiovascular Diseases Vasculitis Skin Diseases, Vascular Skin Diseases Autoimmune Diseases Immune System Diseases Infliximab Dermatologic Agents Therapeutic Uses Pharmacologic Actions Gastrointestinal Agents Antirheumatic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 19, 2013