Overview

Single Dose PG102 in Patients With Active Psoriatic Arthritis

Status:
Terminated
Trial end date:
2010-05-01
Target enrollment:
0
Participant gender:
All
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 around the body and to explore its effects on the disease.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
PanGenetics UK Limited
Treatments:
Antibodies
Antibodies, Monoclonal
Criteria
Inclusion Criteria:

- Arthritis that meets Classification of Psoriatic Arthritis (CASPAR) criteria

- Plaque psoriasis for at least 6 months prior to study enrollment

Exclusion Criteria:

- 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