Study of Tocilizumab to Treat Polymyalgia Rheumatica

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Robert Spiera, MD, Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01396317
First received: July 11, 2011
Last updated: March 18, 2015
Last verified: March 2015

July 11, 2011
March 18, 2015
July 2011
December 2015   (final data collection date for primary outcome measure)
  • Proportion of Patients in Disease Remission at Six Months from Trial Entry [ Time Frame: Six months ] [ Designated as safety issue: No ]

    The co-primary endpoints for this study include efficacy, as well as evaluations of safety and tolerability.

    • Efficacy will be defined by the proportion of patients in Disease Remission (DR) off corticosteroids, without relapse or recurrence, at six months from trial entry
    • Safety and tolerability of Tocilizumab will be evaluated during the fifteen-month study period by the monitoring of adverse events and immunogenicity surveillance
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 15 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01396317 on ClinicalTrials.gov Archive Site
  • Proportion of patients able to achieve Disease Remission (DR) off corticosteroids, without Disease Relapse or Recurrence [ Time Frame: 12 and 15 months from trial entry ] [ Designated as safety issue: No ]
  • Proportion of patients who develop Disease Relapses [ Time Frame: 6, 12 and 15 months from trial entry ] [ Designated as safety issue: No ]
  • The proportion of patients who develop Disease Recurrences [ Time Frame: 6, 12 and 15 months from trial entry ] [ Designated as safety issue: No ]
  • The cumulative dose of prednisone [ Time Frame: 6, 12 and 15 months from trial entry ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Study of Tocilizumab to Treat Polymyalgia Rheumatica
Phase IIa of Tocilizumab In the Treatment of Polymyalgia Rheumatica

This is a fifteen-month open label, Phase IIa clinical trial is being conducted to assess the tolerability, safety and efficacy of a medication called Tocilizumab (Actemra®) in patients with polymyalgia rheumatica (PMR).

This fifteen-month open label, Phase IIa clinical trial is being conducted to assess the tolerability, safety and efficacy of a medication called Tocilizumab (Actemra®) in patients with polymyalgia rheumatica (PMR). The typical symptoms of PMR are muscle pain and stiffness in the shoulder, neck or hip region. Steroids have traditionally been used to treat this condition with great success, although long courses of steroids, up to 2 years in many cases, are often required. This can result in many unwanted side effects including diabetes, high blood pressure, heart disease, cataracts, weak bones with fractures, weak muscles, skin bruising, difficulty sleeping and mood disturbances. In this trial, the steroid dosage will be decreased much more quickly than what is done in routine clinical practice; there is an expectation that steroid therapy will be withdrawn within six months.

Tocilizumab is a medication already on the market that has been FDA approved in the US and Japan for the treatment of rheumatoid arthritis, and in Japan it is also approved for certain types of juvenile idiopathic arthritis (which is like rheumatoid arthritis in children) and Castleman's disease (which is a rare disease that causes enlarged lymph nodes). It is not FDA approved to treat polymyalgia rheumatica at this time. In this study, it will be given as an intravenous infusion once a month for a treatment period of one year. Experiments done on the blood of patients with PMR show one particular cytokine or small molecule that circulates throughout the body, interleukin-6, to be elevated in this disease. Tocilizumab is a medication that is designed to specifically block this cytokine. The co-primary endpoints for this study include efficacy, as well as evaluations of safety and tolerability.

  • Efficacy will be defined by the proportion of patients in Disease Remission (DR) off corticosteroids, without relapse or recurrence, at six months from trial entry
  • Safety and tolerability of Tocilizumab will be evaluated during the fifteen-month study period by the monitoring of adverse events and immunogenicity surveillance

Disease Remission (DR) will be defined as the disappearance of signs and symptoms of polymyalgia rheumatica (aching and stiffness of the shoulder, hip girdle, or both) with normalization of erythrocyte sedimentation rate (ESR<30 mm/hr) and c-reactive protein (CRP ≤1.0 mg/dl), unless elevation of ESR and/or CRP are attributable to causes other than PMR (i.e., infection).

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Polymyalgia Rheumatica (PMR)
Drug: Tocilizumab
Tocilizumab is a humanized anti-interleukin-6 receptor antibody that has been FDA approved for the treatment of rheumatoid arthritis (RA). This molecule binds to the IL-6 binding site of human IL-6 receptor, and competitively inhibits IL-6 signaling.
Other Name: Actemra
Experimental: Tocilizumab
This is a single-arm study. All subjects will receive the active study treatment for 12 months, and will then be evaluated for 3 months of long-term follow-up.
Intervention: Drug: Tocilizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
10
December 2015
December 2015   (final data collection date for primary outcome measure)

Disease- Specific Inclusion Criteria:

Patients must meet the following inclusion criteria to be eligible for study entry:

Diagnosed with polymyalgia rheumatica and enrolled within one month of diagnosis.

Disease Specific Exclusion Criteria:

Patients will be excluded from the study based on the following criteria:

  • Symptoms or diagnosis of temporal arteritis, including headache, jaw claudication, hyperesthesia of scalp, abnormal palpated temporal artery, visual disturbances, temporal artery biopsy positivity
  • Concurrent rheumatoid arthritis
  • Presence of rheumatoid factor and CCP
  • Other inflammatory arthritis or other connective tissue diseases, such as but not limited to systemic lupus erythematosus, systemic sclerosis, vasculitis, polymyositis, dermatomyositis, mixed connective tissue disease
  • Treatment of polymyalgia rheumatica with more than 20mg of daily prednisone or its equivalent at the time of screening
  • Treatment with more than 30mg of daily prednisone or its equivalent since diagnosis. Treatment with 30mg of daily prednisone or its equivalent since diagnosis for more than 2 weeks.
  • More than 4 weeks of corticosteroid therapy prior to enrollment
  • History of bowel perforation within the past five years.
  • Active diverticulitis.
  • Pre-existing or recent onset demyelinating disorders
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01396317
11081
Yes
Robert Spiera, MD, Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
Genentech, Inc.
Principal Investigator: Robert F Spiera, MD Hospital for Special Surgery, New York
Hospital for Special Surgery, New York
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP