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Trial record 86 of 117 for:    "Connective Tissue Disease" | "Methylprednisolone"

A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RA

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ClinicalTrials.gov Identifier: NCT00747214
Recruitment Status : Completed
First Posted : September 5, 2008
Results First Posted : May 20, 2014
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
Zalicus

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Rheumatoid Arthritis
Interventions Drug: CRx-102
Drug: Placebo
Drug: DMARD Therapy
Enrollment 59
Recruitment Details  
Pre-assignment Details  
Arm/Group Title CRx-102 Plus DMARD Therapy Placebo Plus DMARD Therapy
Hide Arm/Group Description

Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy

The following dose escalation scheme was used:

Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone)

Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)

Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
Period Title: Overall Study
Started 27 32
Completed 19 29
Not Completed 8 3
Arm/Group Title CRx-102 Plus DMARD Therapy Placebo Plus DMARD Therapy Total
Hide Arm/Group Description

Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy

The following dose escalation scheme was used:

Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)

Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy Total of all reporting groups
Overall Number of Baseline Participants 19 27 46
Hide Baseline Analysis Population Description
Baseline analysis population is equal to the per protocol population defined as the subset of intent to treat population with no major protocol deviations including entry criteria and use of restricted medications and with study drug compliance of at least 75% during Days 1 to 42.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 19 participants 27 participants 46 participants
56.5  (6.53) 60.0  (12.25) 58.5  (10.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 27 participants 46 participants
Female
15
  78.9%
21
  77.8%
36
  78.3%
Male
4
  21.1%
6
  22.2%
10
  21.7%
1.Primary Outcome
Title Change in CRP From Baseline to Day 42
Hide Description The primary efficacy variable in this study was the change in CRP from Baseline (Day 1/Visit 2) to End of Study (Day 42/Visit 5). Blood samples for the analysis of serum CRP were taken at each visit.
Time Frame Baseline and Day 42
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRx-102 Plus DMARD Therapy Placebo Plus DMARD Therapy
Hide Arm/Group Description:

Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy

The following dose escalation scheme was used:

Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)

Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
Overall Number of Participants Analyzed 19 27
Mean (Standard Deviation)
Unit of Measure: percentage change from baseline
-16.12  (94.99) 9.60  (74.15)
2.Secondary Outcome
Title Improvement of ACR 20 Scores at End of Study (Day 42/Visit 5)
Hide Description The percentage of subjects in each group that achieved an ACR 20 response on Day 42
Time Frame Day 42
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRx-102 Plus DMARD Therapy Placebo Plus DMARD Therapy
Hide Arm/Group Description:

Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy

The following dose escalation scheme was used:

Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)

Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
Overall Number of Participants Analyzed 19 27
Measure Type: Number
Unit of Measure: percentage of participants
63 30
3.Secondary Outcome
Title Change in DAS28 Score From Baseline to Day 42
Hide Description To calculate the DAS28, the number of swollen joints and tender joints should be assessed using 28-joint counts, the ESR should have been measured in mm/hour, and the patient's general health (GH) or global disease activity measured on a Visual Analog Scale (VAS) of 100 mm must be obtained. Using these data, the DAS28 could be calculated using the following formula: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The DAS28 provides a number between 0 and 10 that indicates the current activity of RA in the subject. A DAS28 above 5.1 means high disease activity and below 3.2 indicates low activity. Remission is achieved when a DAS28 score is lower than 2.6. The DAS28 measurements were to be taken at each visit.
Time Frame Baseline and Day 42
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRx-102 Plus DMARD Therapy Placebo Plus DMARD Therapy
Hide Arm/Group Description:

Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy

The following dose escalation scheme was used:

Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)

Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
Overall Number of Participants Analyzed 19 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.521  (1.574) -0.697  (1.435)
4.Secondary Outcome
Title Change in Fatigue (MAF Scale) Score From Baseline to Day 42
Hide Description

The Multidimensional Assessment of Fatigue (MAF) scale is a self-administered, 16 item questionnaire to measure self-reported fatigue (http://www.son.washington.edu/research/maf/). The following steps were used to calculate a single score ranging from 1 (no fatigue) to 50 (severe fatigue).

  1. Convert item #15 to a 0 to 10 scale by multiplying each score by 2.5
  2. Sum items #1, 2, and 3
  3. Average items #4 through 14
  4. Add results from above Steps 1 through 3 to obtain a single score

A score was not be assigned to items #4 through 14 if a respondent indicated they "did not engage any activity for reasons other than fatigue." If respondent selected “no fatigue” on item #1, a 0 was to be assigned to items #2 through 16; item #16 was not included in the global fatigue index.

Time Frame Baseline and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title CRx-102 Plus DMARD Therapy Placebo Plus DMARD Therapy
Hide Arm/Group Description:

Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy

The following dose escalation scheme was used:

Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone)

Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
Overall Number of Participants Analyzed 19 27
Mean (Standard Deviation)
Unit of Measure: units on a scale
-7.840  (10.605) -2.965  (9.186)
Time Frame 8 weeks: from screening (visit 1) up to 14 days prior to baseline (visit 2) through end of study (visit 5) on day 42.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title CRx-102 Plus DMARD Therapy Placebo Plus DMARD Therapy
Hide Arm/Group Description

Daily oral treatment with CRx-102, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy

The following dose escalation scheme was used:

Days 1 to 7 Dose level 1: CRx-102 (200 mg dipyridamole + 3 mg prednisolone) or placebo equivalent Days 8 to 42 Dose level 2: CRx-102 (400 mg dipyridamole + 3 mg prednisolone) or placebo equivalent

Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
All-Cause Mortality
CRx-102 Plus DMARD Therapy Placebo Plus DMARD Therapy
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
CRx-102 Plus DMARD Therapy Placebo Plus DMARD Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      1/32 (3.13%)    
Gastrointestinal disorders     
femoral hernia * 1 [1]  0/27 (0.00%)  0 1/32 (3.13%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Left femoral hernia that required hospitalization and surgical correction. In the opinion of the investigator this event was not related to study drug.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
CRx-102 Plus DMARD Therapy Placebo Plus DMARD Therapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   20/27 (74.07%)      13/32 (40.63%)    
Gastrointestinal disorders     
Nausea * 1  7/27 (25.93%)  2/32 (6.25%) 
Vomiting * 1  6/27 (22.22%)  1/32 (3.13%) 
Diarrhea * 1  3/27 (11.11%)  1/32 (3.13%) 
Musculoskeletal and connective tissue disorders     
Rheumatoid arthritis * 1  1/27 (3.70%)  5/32 (15.63%) 
Nervous system disorders     
Headache * 1  13/27 (48.15%)  0/32 (0.00%) 
Dizziness * 1  3/27 (11.11%)  1/32 (3.13%) 
Respiratory, thoracic and mediastinal disorders     
Cough * 1  0/27 (0.00%)  3/32 (9.38%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (10.0)
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.
Results Point of Contact
Name/Title: Margaret Lee, PhD
Organization: Zalicus
Phone: 617-301-7142
Responsible Party: Zalicus
ClinicalTrials.gov Identifier: NCT00747214     History of Changes
Other Study ID Numbers: CRx-102-002
First Submitted: September 3, 2008
First Posted: September 5, 2008
Results First Submitted: January 16, 2014
Results First Posted: May 20, 2014
Last Update Posted: May 20, 2014