Status:
UNKNOWN
Infliximab Therapy in Patients With Refractory Polymyalgia Rheumatica
Lead Sponsor:
Hospital Universitario Marqués de Valdecilla
Collaborating Sponsors:
Schering-Plough
Conditions:
Polymyalgia Rheumatica
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief 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 ne...
Detailed Description
The duration of the study will be 1 year, and it will be divided in several phases: A) Initial phase (double-blind trial): Between week 0 and week 24. Placebo or Infliximab at a dose of 3 mg/kg/day a...
Eligibility Criteria
Inclusion
- 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
- -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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT01423591
Start Date
June 1 2007
End Date
December 1 2011
Last Update
August 26 2011
Active Locations (1)
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1
Reumatology division, Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008