A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
Condition: Polymyalgia Rheumatica; Inflammatory Diseases
MeSH terms: Polymyalgia Rheumatica; Giant Cell Arteritis
Intervention: AIN457; ACZ885; Prednisone; Placebo
Intervention description: 3 mg/kg; 3 mg/kg; 20 mg; Matching placebo to AIN457, ACZ885 and prednisone
Intervention MeSH terms: Prednisone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Polymyalgia Rheumatica; Inflammatory Disease; Rheumatic Disease

Summary:

      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.
    

Eligibility criteria:

        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.

        Other protocol-defined inclusion/exclusion criteria apply