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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-14

Study Completion Date

2013-01-29

Brief Summary

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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 maximum 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.

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Detailed Description

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Conditions

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Polymyalgia Rheumatica Inflammatory Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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ACZ885

On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.

Group Type EXPERIMENTAL

AIN457

Intervention Type DRUG

3 mg/kg

Placebo

Intervention Type DRUG

Matching placebo to AIN457, ACZ885 and prednisone

AIN457

On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.

Group Type EXPERIMENTAL

ACZ885

Intervention Type DRUG

3 mg/kg

Placebo

Intervention Type DRUG

Matching placebo to AIN457, ACZ885 and prednisone

Prednisone

On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.

Group Type OTHER

Prednisone

Intervention Type DRUG

20 mg

Placebo

Intervention Type DRUG

Matching placebo to AIN457, ACZ885 and prednisone

Interventions

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AIN457

3 mg/kg

Intervention Type DRUG

ACZ885

3 mg/kg

Intervention Type DRUG

Prednisone

20 mg

Intervention Type DRUG

Placebo

Matching placebo to AIN457, ACZ885 and prednisone

Intervention Type DRUG

Other Intervention Names

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canakinumab

Eligibility Criteria

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Inclusion Criteria

* Patients must meet all of the following features:
* Patients ≥ 50 and ≤ 85 years
* C-reactive protein (CRP) \> 1.0 mg/dl OR erythrocyte sedimentation rate (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 purified protein derivative skin test (PPD) skin test (≤ 5 mm induration) at screening

Exclusion Criteria

* Active infection or current use of antibiotics
* Known human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatits B virus (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 Giant Cell Artertitis (GCA), spondyloarthropathies), connective tissue disease, drug-induced myopathies, endocrine disorders, neurological disorders, chronic pain syndromes, as assessed by base line screening including thyroid-stimulating hormone (TSH), creatine kinase (CK), rheumatoid factor (RF), cyclic citrullinated peptide (CCP), antinuclear antibodies (ANA), serum protein electrophoresis, urinalysis.

Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No