A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
Polymyalgia Rheumatica, Inflammatory Diseases
About this trial
This is an interventional treatment trial for Polymyalgia Rheumatica focused on measuring Polymyalgia Rheumatica, Inflammatory Disease, Rheumatic Disease
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
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Other
ACZ885
AIN457
Prednisone
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.
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.
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.