A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01364389
First received: March 10, 2011
Last updated: March 12, 2013
Last verified: March 2013

March 10, 2011
March 12, 2013
February 2011
June 2013   (final data collection date for primary outcome measure)
To assess the efficacy of a single dose of AIN457 and ACZ885 (canakinmab) separately after 2 weeks as measured by the polymyalgia rheumatica activity score. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01364389 on ClinicalTrials.gov Archive Site
  • To assess the time to partial clinical response in patients who respond to a single dose of AIN457 or ACZ885 (canakinumab) with daily monitoring (homebased) of the lab parameter CRP, an indicator of inflammation [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the time to complete response (days) in responders to a single dose of either AIN457 or ACZ885 (canakinumab) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the time to first flare in patients who respond to a single dose of AIN457 or ACZ885 (canakinumab) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the effect of AIN457 and ACZ885 (canakinumab) on the number of flares over a 6 month period [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the effect of AIN457 and ACZ885 (canakinumab) on the cumulative and/or mean steroid dose over a 6 month period [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of AIN457 and ACZ885 (canakinumab) in patients with polymyalgia rheumatica by monitoring different standard lab parameters throughout the study period and collecting information on adverse events including infections [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • To characterize the concentrations (Pharmacokinetics) of AIN457 and ACZ885 (canakinumab) in blood serum in patients with polymyalgia rheumatica [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
  • To compare the initial response to AIN457 and ACZ885 (canakinumab) with the response after re-dosing of AIN457 and ACZ885 (canakinumab) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess the effect on health-related quality of life (HAQ, SF-36) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
A 2-week Single-blind, Randomized, 3-arm Proof of Concept Study of the Effects of AIN457 (Anti-IL17 Antibody), ACZ885 (Canakinumab, Anti-IL1b Antibody), or Corticosteroids on Initial Disease Activity Scores in Patients With Polymyalgia Rheumatica, Followed by an Open Label Phase to Assess Safety and Long Term Efficacy

The study is a two-week, single-blinded, double-dummy, randomized, active-controlled, parallel group design, with a follow-up period up to a total study duration of 6-month, non-randomized, open-label phase to monitor safety, tolerability and, in responders, flare. It is a multicentric, multinational study. The protocol will seek to enroll a total of 30 patients, who will be randomized to the 3 arms at a ratio of 1:1:1.

Patients will have a max. screening period of 7 days with randomization at D1 for a dosing period of 15 days followed by a follow up-period of 154 days, or 4 months (112 days) after their last biologic dose, whichever is greater, and followed by unblinded re-dosing in the case of a disease flare.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
  • Polymyalgia Rheumatica
  • Inflammatory Diseases
  • Drug: AIN457
  • Drug: ACZ885 (canakinumab)
  • Drug: Prednisone
  • Experimental: AIN457
    Intervention: Drug: AIN457
  • Experimental: ACZ885
    Intervention: Drug: ACZ885 (canakinumab)
  • Prednisone
    Intervention: Drug: Prednisone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
27
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must meet all of the following features:
  • Patients ≥ 50 and ≤ 85 years of
  • CRP > 1.0 mg/dl OR ESR > 30 mm/hr
  • New bilateral shoulder and/or hip pain
  • Early morning stiffness > 60 min
  • Duration of illness > 1 week
  • A negative 5 U PPD skin test (≤ 5 mm induration) at screening

Exclusion Criteria:

  • Active infection or current use of antibiotics
  • Known HIV, HCV or HBV
  • Previous therapy with methotrexate or other immunosuppressive agents within three months prior to baseline
  • History of malignancy other than a successfully treated non-metastatic cutaneous squamous cell or basal cell carcinoma and/or localized carcinoma in situ of the cervix within five years prior to study entry
  • Presence of rheumatoid arthritis or other inflammatory arthritic processes (features of GCA (Giant Cell Artertitis), spondyloarthropathies), connective tissue disease, drug-induced myopathies, endocrine disorders, neurological disorders, chronic pain syndromes, as assessed by base line screening including TSH, CK, RF, CCP, ANA, serum protein electrophoresis, urinalysis.

Other protocol-defined inclusion/exclusion criteria apply

Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   United Kingdom
 
NCT01364389
CPJMR0012201, 2010-019395-73
Not Provided
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
March 2013

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