A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Polymyalgia Rheumatica, Inflammatory Diseases
In brief
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.
Key facts
- Study ID
- NCT01364389
- Run by
- Novartis Pharmaceuticals
- People needed
- 16
- Starts
- 2011-02-14
- Expected to finish
- 2013-01-29
- Last updated by the study team
- 2021-09-17
Who can join
Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Novartis Investigative Site — Rochester, Minnesota, United States
- Novartis Investigative Site — Berlin, Germany
- Novartis Investigative Site — Reggio Emilia, RE, Italy
- Novartis Investigative Site — Siena, SI, Italy
- Novartis Investigative Site — Basildon, Essex, United Kingdom
- Novartis Investigative Site — Westcliff-on-Sea, Essex, United Kingdom
Full record on ClinicalTrials.gov
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