Status:
TERMINATED
Single Dose PG102 in Patients With Active Psoriatic Arthritis
Lead Sponsor:
PanGenetics UK Limited
Conditions:
Arthritis, Psoriatic
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
The primary objective is to evaluate the safety and tolerability of a single intravenous dose of PG102 in patients with psoriatic arthritis. The secondary objectives are to evaluate how PG102 moves ar...
Eligibility Criteria
Inclusion
- Arthritis that meets Classification of Psoriatic Arthritis (CASPAR) criteria
- Plaque psoriasis for at least 6 months prior to study enrollment
Exclusion
- Clinically significant psoriasis flare
- Unstable doses of pain relief medication
- Treatment with systemic corticosteroids other than prednisone ≤ 10 mg/day or equivalent
- Treatment with any biologic therapy
- Treatment with immunosuppressive agents or disease modifying anti-rheumatic drugs (DMARDs) other than methotrexate
- Treatment with lithium, any anti-malarial, chlorambucil, cyclophosphamide or therapies for psoriasis other than low potency topical corticosteroids on intertriginous and groin areas, tar or salicylate preparations on the scalp, and emollients and moisturisers
- Family history of multiple thrombotic events or a personal history of any venous or arterial thrombotic event
- Clinically significant result for anti-cardiolipin, Activated protein C resistance test, Protein C, Free Protein S, Antithrombin III, Factor V Leiden, Prothrombin variant, Homocysteine, Lupus anticoagulant, Prothrombin time, Activated partial thromboplastin time, Fibrinogen, Thrombin time, Factors IX and XI
- Currently smoking ≥ 10 cigarettes per day or equivalent
- Active tuberculosis or other infection
- Current or previous malignancies
- Clinically significant abnormality on physical examination, laboratory testing, vital signs or 12-lead electrocardiogram
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00787137
Start Date
December 1 2008
End Date
May 1 2010
Last Update
October 26 2010
Active Locations (1)
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1
Professor Nemanja Damjanov
Belgrade, Serbia