A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis (Synergy)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zalicus
ClinicalTrials.gov Identifier:
NCT01369745
First received: June 7, 2011
Last updated: April 29, 2014
Last verified: April 2014
Results First Received: February 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Rheumatoid Arthritis
Interventions: Drug: Prednisolone
Drug: dipyridamole
Drug: Prednisone
Drug: Z102
Other: placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 294 subjects entered the titration phase. Of these, 258 subjects completed the titration phase, were randomized to treatment, received at least one dose of study drug and constitute the safety population. Of these, 252 subjects provided at least one post-baseline measurement of the primary endpoint and constitute the efficacy population.

Reporting Groups
  Description
Prednisolone Prednisolone 2.7 mg once daily
Dipyridamole dipyridamole 360 mg once daily
Prednisone Prednisone 5 mg once daily
Z102 2.7 mg prednisolone plus 360 mg dipyridamole once daily
Placebo placebo once daily

Participant Flow:   Overall Study
    Prednisolone     Dipyridamole     Prednisone     Z102     Placebo  
STARTED     32     41     18     84     83  
COMPLETED     25     28     16     64     65  
NOT COMPLETED     7     13     2     20     18  



  Baseline Characteristics
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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.
population randomized to double blind phase of study and recieved at least one dose of study drug

Reporting Groups
  Description
Prednisolone Prednisolone 2.7 mg once daily The trial would progress from Stage 1 to Stage 2 if the posterior probability that Z102 is superior to placebo was greater than 0.975.
Dipyridamole dipyridamole 360 mg once daily The trial would progress from Stage 2 to Stage 3 if the posterior probability that Z102 is superior to dipyridamole was greater than 0.975.
Prednisone Prednisone 5 mg once daily The trial would progress from Stage 2 to Stage 4 if the posterior probability that Z102 is superior to prednisolone 2.7 was greater than 0.975.
Z102 prednisolone 2.7 mg plus dipyridamole 360 mg once daily The trial would progress from Stage 3 to Stage 5 if the posterior probability that Z102 is superior to prednisolone 2.7 was greater than 0.975.
Placebo placebo once daily
Total Total of all reporting groups

Baseline Measures
    Prednisolone     Dipyridamole     Prednisone     Z102     Placebo     Total  
Number of Participants  
[units: participants]
  32     41     18     84     83     258  
Age  
[units: years]
Mean ± Standard Deviation
  55.2  ± 12.69     55.9  ± 9.35     55.5  ± 9.82     54.5  ± 11.53     53.7  ± 12.44     54.6  ± 11.5  
Gender  
[units: participants]
           
Female     26     36     17     72     75     226  
Male     6     5     1     12     8     32  



  Outcome Measures
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1.  Primary:   Change From Baseline in DAS28-CRP at 12 Weeks   [ Time Frame: baseline to week 12 ]

2.  Secondary:   Change From Baseline in DAS28-CRP Individual Components at 12 Weeks   [ Time Frame: Baseline to week 12 ]

3.  Secondary:   Percentage of Subjects Achieving ACR20, ACR50 and ACR70 at 12 Weeks   [ Time Frame: Week 12 ]

4.  Secondary:   Multidimensional Assessment of Fatigue (MAF) at Week 12   [ Time Frame: week 12 ]

5.  Secondary:   Time to Failure (Days)   [ Time Frame: Baseline to 12 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The study did not progress past the first stage of adaptive randomization. The number of subjects allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg arms was insufficient to allow analysis of the secondary objectives.


  More Information
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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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Margaret Lee,PhD
Organization: Zalicus
phone: 617-301-7142
e-mail: mlee@zalicus.com


No publications provided


Responsible Party: Zalicus
ClinicalTrials.gov Identifier: NCT01369745     History of Changes
Other Study ID Numbers: Z102-008
Study First Received: June 7, 2011
Results First Received: February 10, 2014
Last Updated: April 29, 2014
Health Authority: United States: Food and Drug Administration