- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00787137
Single Dose PG102 in Patients With Active Psoriatic Arthritis
October 15, 2010 updated by: PanGenetics UK Limited
A Randomised, Double Blind, Placebo Controlled, Single Ascending Dose, Phase I Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of PG102 (Anti-CD40 Monoclonal Antibody) In Patients With Active Psoriatic Arthritis
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Belgrade, Serbia
- Professor Nemanja Damjanov
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PG102 0.3 mg/kg
Lowest dose PG102
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A single intravenous infusion
Other Names:
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Experimental: PG102 1 mg/kg
Second dose PG102
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A single intravenous infusion
Other Names:
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Placebo Comparator: Placebo (phosphate-buffered saline)
Control
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Phosphate-buffered saline
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Number of Reported Adverse Events
Time Frame: Three months
|
This was an exploratory study and all safety endpoints were considered.
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Three months
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The Percentage of Participants With Adverse Events
Time Frame: Three months
|
Three months
|
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The Number of Episodes of Change in Vital Signs
Time Frame: Three months
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Clinically significant episodes of change in blood pressure, heart rate, temperature or respiration rate on the day before dosing and 0.5, 1, 2, 3, 4, 6, 8, 12 and 24 hours and 4, 7, 14, 21, 28, 56 & 84 days after dosing.
The investigator evaluated clinical significance primarily by blinded comparison with the respective screening value.
|
Three months
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The Number of Episodes of Change in Electrocardiogram
Time Frame: Three months
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Episodes of clinically significant change in 12-lead electrocardiogram predose,1 & 4 hours and 1 & 84 days postdose.
The investigator evaluated clinical significance primarily by blinded comparison with the screening electrocardiogram.
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Three months
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The Number of Episodes of Change From Screening in Laboratory Assessments
Time Frame: Three months
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Red cell count, haemoglobin, haematocrit, total and differential white cell counts, platelet count, mean corpuscular volume, mean corpuscular haemoglobin, mean corpuscular haemoglobin concentration, reticulocytes; urea, creatinine, urate, bilirubin, sodium, potassium, calcium, phosphate, chloride, bicarbonate, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase, gammaglutamyl transferase, creatine phosphokinase, albumin, protein; urine pH, protein, glucose, ketones, bilirubin, blood, urobilinogen, nitrite, leucocytes, specific gravity.
|
Three months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Nemanja Damjanov, MD PhD, Institute of Rheumatology, Belgrade, Serbia
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (Actual)
April 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
November 6, 2008
First Submitted That Met QC Criteria
November 6, 2008
First Posted (Estimate)
November 7, 2008
Study Record Updates
Last Update Posted (Estimate)
October 26, 2010
Last Update Submitted That Met QC Criteria
October 15, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PG102-01
- 2007-001017-42 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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