Study of Tocilizumab to Treat Polymyalgia Rheumatica

NCT01396317 | Completed Phase 2 Results DMC

• 1 other identifier: 11081
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Polymyalgia Rheumatica (PMR)

Keywords

PMR; POLYMYALGIA RHEUMATICA; Tocilizumab; Hospital for Special Surgery; HSS; Robert Spiera

Outcome Measures

Primary Outcomes (2)

• Proportion of Patients in Disease Remission at Six Months From Trial Entry

  The co-primary endpoints for this study include efficacy: • 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 Relapse was defined as the reappearance of signs and symptoms of PMR, accompanied by an increasing erythrocyte sedimentation rate and/or C-reactive protein level attributable to disease activity. Recurrence was similarly defined as the return of PMR symptoms in conjunction with elevations in levels of inflammation markers, occurring 1 month after discontinuation of glucocorticoid therapy.

  Six months

• Number of Participants With Adverse Events as a Measure of Safety and Tolerability

  The co-primary endpoints for this study include evaluations of safety and tolerability: • Safety and tolerability of Tocilizumab will be evaluated during the fifteen-month study period by the monitoring of adverse events and immunogenicity surveillance

  15 months

Secondary Outcomes (4)

• Proportion of Patients Able to Achieve Disease Remission (DR) Off Corticosteroids, Without Disease Relapse or Recurrence

  12 and 15 months from trial entry

• Proportion of Patients Who Develop Disease Relapses

  6, 12 and 15 months from trial entry

• The Cumulative Dose of Prednisone

  6, 12 and 15 months from trial entry

• Total Number of Relapses/Recurrences

  12 months

Study Arms (1)

Tocilizumab

EXPERIMENTAL

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.

Drug: Tocilizumab

Interventions

Tocilizumab DRUG

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.

Also known as: Actemra

Tocilizumab

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 100214898, United States

Location

MeSH Terms

Conditions

Polymyalgia Rheumatica

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Dr. Robert Spiera
• Organization: Hospital for Special Surgery

spierar@hss.edu

212-774-2048

Study Officials

• Robert F Spiera, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2011
• First Posted: July 18, 2011
• Study Start: April 1, 2011
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: January 17, 2018
• Results First Posted: January 17, 2018

Record last verified: 2018-01

Locations

US (1)