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Infliximab Therapy in Patients With Refractory Polymyalgia Rheumatica

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ClinicalTrials.gov Identifier: NCT01423591
Recruitment Status : Unknown
Verified August 2011 by Dr. Vicente Rodri-guez Valverde, Hospital Universitario Marqués de Valdecilla.
Recruitment status was:  Active, not recruiting
First Posted : August 26, 2011
Last Update Posted : August 26, 2011
Sponsor:
Collaborator:
Schering-Plough
Information provided by (Responsible Party):
Dr. Vicente Rodri-guez Valverde, Hospital Universitario Marqués de Valdecilla

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 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 or disease Intervention/treatment Phase
Polymyalgia Rheumatica Drug: infliximab Drug: inactive powder Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Infliximab Therapy in Patients With Refractory Polymyalgia Rheumatica: a Double Blind Placebo Controlled Trial
Study Start Date : June 2007
Primary Completion Date : September 2010
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Infliximab
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Proportion of responders(complete remission without corticosteroids) [ Time Frame: at 24 weeks ]

Secondary Outcome Measures :
  1. Proportion of responders [ Time Frame: at 48 weeks ]
  2. Time to response [ Time Frame: 48 weeks ]
  3. Number of relapses / recurrences [ Time Frame: 48 weeks ]
  4. Response duration [ Time Frame: 48 weeks ]
  5. Cumulative dose and side effects of steroids [ Time Frame: at 24 and 48 weeks ]
  6. Number of patients that should be re-treated with infliximab [ Time Frame: 48 weeks ]
  7. Side effects of Infliximab in this patient population [ Time Frame: 48 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011

Keywords provided by Dr. Vicente Rodri-guez Valverde, 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
Vascular Diseases
Cardiovascular Diseases
Arteritis
Vasculitis
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents