A 3-arm Proof of Concept Study of AIN457, ACZ885 or Corticosteroids in Patients With Polymyalgia Rheumatica
| Status: | Terminated |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 50 - 85 |
| Updated: | 5/6/2018 |
| Start Date: | February 14, 2011 |
| End Date: | January 29, 2013 |
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 in Patients With Polymyalgia Rheumatica, Followed by an Open Label Phase to Assess Safety and Long Term Efficacy
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.
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.
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
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