Single Dose PG102 in Patients With Active Psoriatic Arthritis

This study has been terminated.
(poor recruitment)
Sponsor:
Information provided by:
PanGenetics UK Limited
ClinicalTrials.gov Identifier:
NCT00787137
First received: November 6, 2008
Last updated: October 15, 2010
Last verified: October 2010
Results First Received: August 12, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Arthritis, Psoriatic
Interventions: Drug: PG102
Drug: Placebo comparator

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
PG102 0.3 mg/kg Lowest dose PG102
PG102 1 mg/kg Second dose PG102
Placebo Control, phosphate-buffered saline

Participant Flow:   Overall Study
    PG102 0.3 mg/kg     PG102 1 mg/kg     Placebo  
STARTED     6     6     5  
COMPLETED     6     6     4  
NOT COMPLETED     0     0     1  
Study Termination                 0                 0                 1  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
PG102 0.3 mg/kg Lowest dose PG102
PG102 1 mg/kg Second dose PG102
Placebo Control, phosphate-buffered saline
Total Total of all reporting groups

Baseline Measures
    PG102 0.3 mg/kg     PG102 1 mg/kg     Placebo     Total  
Number of Participants  
[units: participants]
  6     6     5     17  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     6     6     5     17  
>=65 years     0     0     0     0  
Age  
[units: years]
Mean ( Full Range )
  43.3  
  ( 32 to 54 )  
  43.8  
  ( 27 to 59 )  
  45.2  
  ( 31 to 58 )  
  44.0  
  ( 27 to 59 )  
Gender  
[units: participants]
       
Female     1     0     1     2  
Male     5     6     4     15  
Region of Enrollment  
[units: Participants]
       
Serbia     2     5     2     9  
Hungary     4     1     3     8  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Number of Reported Adverse Events   [ Time Frame: Three months ]

2.  Primary:   The Percentage of Participants With Adverse Events   [ Time Frame: Three months ]

3.  Primary:   The Number of Episodes of Change in Vital Signs   [ Time Frame: Three months ]

4.  Primary:   The Number of Episodes of Change in Electrocardiogram   [ Time Frame: Three months ]

5.  Primary:   The Number of Episodes of Change From Screening in Laboratory Assessments   [ Time Frame: Three months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Termination prior to accrual of planned numbers of participants


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: John Powell
Organization: PanGenetics UK Limited
phone: +441763257869
e-mail: info@pangenetics.com


No publications provided


Responsible Party: John Powell, PanGenetics UK Limited
ClinicalTrials.gov Identifier: NCT00787137     History of Changes
Other Study ID Numbers: PG102-01, 2007-001017-42
Study First Received: November 6, 2008
Results First Received: August 12, 2010
Last Updated: October 15, 2010
Health Authority: Serbia: Agency for Medicines and Medical Devices
Hungary: National Institute of Pharmacy
Russia: Ministry of Health of the Russian Federation