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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-001017-42 | EudraCT Number |
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poor recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PG102 0.3 mg/kg | Experimental | Lowest dose PG102 |
|
| PG102 1 mg/kg | Experimental | Second dose PG102 |
|
| Placebo (phosphate-buffered saline) | Placebo Comparator | Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PG102 | Drug | A single intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Reported Adverse Events | This was an exploratory study and all safety endpoints were considered. | Three months |
| The Percentage of Participants With Adverse Events | Three months | |
| The Number of Episodes of Change in Vital Signs | 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 |
| The Number of Episodes of Change in Electrocardiogram | 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. | Three months |
| The Number of Episodes of Change From Screening in Laboratory Assessments | 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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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nemanja Damjanov, MD PhD | Institute of Rheumatology, Belgrade, Serbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Professor Nemanja Damjanov | Belgrade | Serbia |
The first three patients in each cohort were dosed sequentially and could not be taking methotrexate. Subsequent patients in each cohort could be dosed simultaneously and could be taking methotrexate. There was a pause between dosing the last patient in the first cohort and the first patient in the second cohort.
Eight study sites (rheumatology centres) in Serbia (3), Hungary (4) and the Russian Federation (1). The first patient's first visit was on December 2, 2008 and the last visit for the last patient was on April 21, 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | PG102 0.3 mg/kg | Lowest dose PG102 |
| FG001 | PG102 1 mg/kg | Second dose PG102 |
| FG002 | Placebo | Control, phosphate-buffered saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | PG102 0.3 mg/kg | Lowest dose PG102 |
| BG001 | PG102 1 mg/kg | Second dose PG102 |
| BG002 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Reported Adverse Events | This was an exploratory study and all safety endpoints were considered. | All adverse events reported for all patients dosed were evaluated | Posted | Number | Number of adverse events | Three months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PG102 0.3 mg/kg | Lowest dose PG102 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Transaminases increased/hepatic enzymes increased | Investigations | MedDRA 12.1 | Non-systematic Assessment | The term for transaminases increased and hepatic enzymes increased have been grouped together because the events were comparable in ALT/AST ratio, involvement or lack of involvement of other analytes and in time of onset. |
Termination prior to accrual of planned numbers of participants
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Powell | PanGenetics UK Limited | +441763257869 | info@pangenetics.com |
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| ID | Term |
|---|---|
| D015535 | Arthritis, Psoriatic |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
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| Placebo comparator | Drug | Phosphate-buffered saline |
|
| Placebo |
Control, phosphate-buffered saline |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
|
|
| Primary | The Percentage of Participants With Adverse Events | All patients dosed were evaluated | Posted | Number | Percentage of Participants | Three months |
|
|
|
| Primary | The Number of Episodes of Change in Vital Signs | 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. | Posted | Number | Number of episodes of change | Three months |
|
|
|
| Primary | The Number of Episodes of Change in Electrocardiogram | 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. | Posted | Number | Number of episodes of change | Three months |
|
|
|
| Primary | The Number of Episodes of Change From Screening in Laboratory Assessments | 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. | Posted | Number | Number of episodes of change | Three months |
|
|
|
| 0 |
| 6 |
| 3 |
| 6 |
| EG001 | PG102 1 mg/kg | Second dose PG102 | 0 | 6 | 4 | 6 |
| EG002 | Placebo | Control, phosphate-buffered saline | 0 | 5 | 2 | 5 |
|
| Dizziness | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Leucocytosis | Blood and lymphatic system disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Neutrophil count increased | Investigations | MedDRA 12.1 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 12.1 | Non-systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 12.1 | Non-systematic Assessment |
|
An investigator shall not publish any data (poster, abstract, paper etc) without having consulted with the Sponsor in advance.
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D011565 | Psoriasis |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |