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

Purpose

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.

Condition	Intervention	Phase
Polymyalgia Rheumatica Inflammatory Diseases	Drug: AIN457 Drug: ACZ885 (canakinumab) Drug: Prednisone	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Giant Cell Arteritis Polymyalgia Rheumatica Steroids

Drug Information available for: Prednisone Canakinumab

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Enrollment:	27
Study Start Date:	February 2011
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AIN457	Drug: AIN457
Experimental: ACZ885	Drug: ACZ885 (canakinumab)
Prednisone	Drug: Prednisone

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01364389

Locations

Germany
Novartis Investigative Site
Berlin, Germany, 13125
Italy
Novartis Investigative Site
Reggio Emilia, RE, Italy, 42100
Novartis Investigative Site
Siena, SI, Italy, 53100
United Kingdom
Novartis Investigative Site
Westcliff-on-Sea, United Kingdom, SS0 0RY

Sponsors and Collaborators

Novartis Pharmaceuticals

Investigators

Study Director:

Novartis Pharmaceuticals

More Information

No publications provided

Responsible Party:	Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:	NCT01364389 History of Changes
Other Study ID Numbers:	CPJMR0012201, 2010-019395-73
Study First Received:	March 10, 2011
Last Updated:	March 12, 2013
Health Authority:	United States: Food and Drug Administration United Kingdom: Medicines and Healthcare Products Regulatory Agency Germany: Ministry of Health

Keywords provided by Novartis:

Polymyalgia Rheumatica
Inflammatory Disease
Rheumatic Disease

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
Prednisone
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 19, 2013