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Single Dose PG102 in Patients With Active Psoriatic Arthritis

NCT ID: NCT00787137

Last Updated: 2010-10-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Arthritis, Psoriatic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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PG102 0.3 mg/kg

Lowest dose PG102

Group Type EXPERIMENTAL

PG102

Intervention Type DRUG

A single intravenous infusion

PG102 1 mg/kg

Second dose PG102

Group Type EXPERIMENTAL

PG102

Intervention Type DRUG

A single intravenous infusion

Placebo (phosphate-buffered saline)

Control

Group Type PLACEBO_COMPARATOR

Placebo comparator

Intervention Type DRUG

Phosphate-buffered saline

Interventions

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PG102

A single intravenous infusion

Intervention Type DRUG

Placebo comparator

Phosphate-buffered saline

Intervention Type DRUG

Other Intervention Names

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Anti-CD40 monoclonal antibody

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PanGenetics UK Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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PanGenetics UK Limited

Principal Investigators

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Nemanja Damjanov, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Institute of Rheumatology, Belgrade, Serbia

Locations

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Professor Nemanja Damjanov

Belgrade, , Serbia

Site Status

Countries

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Serbia

Other Identifiers

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2007-001017-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PG102-01

Identifier Type: -

Identifier Source: org_study_id