Infliximab Therapy in Patients With Refractory Polymyalgia Rheumatica

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Hospital Universitario Marqués de Valdecilla.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Dr. Vicente Rodri-guez Valverde, Hospital Universitario Marqués de Valdecilla
ClinicalTrials.gov Identifier:
NCT01423591
First received: July 19, 2011
Last updated: August 25, 2011
Last verified: August 2011
  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

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Marqués de Valdecilla:

Primary Outcome Measures:
  • Proportion of responders(complete remission without corticosteroids) [ Time Frame: at 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01423591

Locations
Spain
Reumatology division, Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain, 39008
Sponsors and Collaborators
Hospital Universitario Marqués de Valdecilla
Schering-Plough
Investigators
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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 01, 2014