A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RA
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
CRx-102
Placebo
DMARD Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, RA, DMARD, CRP
Eligibility Criteria
Inclusion Criteria:
- Was 18 years of age of older
- Had moderate to severe RA
- Had at least 3 swollen joints (maximum 28) and 3 tender joints (maximum 28)
- Had a Baseline CRP level of at least 2.2 mg/L and a DAS28 score >4.5
- Had been on DMARD therapy for at least 3 months and have been on a stable dose of DMARD therapy for at least 28 days prior to enrollment
- Had a negative pregnancy test (females)
- Was not taking glucocorticoids at screening
Exclusion Criteria:
- Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (barriers or abstinence). Female subjects using hormonal birth control are not to be enrolled.
- Subject is currently taking any steroids (glucocorticoids). All glucocorticoids must be discontinued for at least one month prior to entering study. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study.
- Subject is currently taking more than 81 mg of aspirin daily.
- Subject is currently taking a statin, unless she/he has been on a stable dose of the same statin for at least 3 months prior to entering into the trial.
- Subject has any active infections or recent surgical procedures within 30 days of study initiation.
- Subject has uncontrolled diabetes mellitus as defined by a HbA1C value ≥ 7.0%.
- Subject knowingly has HIV or Hepatitis.
- Subject has undergone administration of any investigational drug within 30 days of study initiation.
- Subject has a history of hypersensitivity to steroids and/or dipyridamole.
- Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CRx-102 plus DMARD therapy
Placebo plus DMARD therapy
Arm Description
Outcomes
Primary Outcome Measures
Change in CRP From Baseline to Day 42
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.
Secondary Outcome Measures
Improvement of ACR 20 Scores at End of Study (Day 42/Visit 5)
The percentage of subjects in each group that achieved an ACR 20 response on Day 42
Change in DAS28 Score From Baseline to Day 42
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.
Change in Fatigue (MAF Scale) Score From Baseline to Day 42
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).
Convert item #15 to a 0 to 10 scale by multiplying each score by 2.5
Sum items #1, 2, and 3
Average items #4 through 14
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00747214
Brief Title
A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RA
Official Title
A Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to That of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects With RA
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zalicus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study was a Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to that of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects with Rheumatoid Arthritis. This Phase II, 6-week blinded study was planned for 60 subjects with moderate to severe rheumatoid arthritis (RA).
Detailed Description
The primary objective of this study was to:
• Compare the response of CRx-102 plus DMARD therapy to placebo plus DMARD therapy in lowering CRP levels in rheumatoid arthritis subjects.
The secondary objectives of this study were to:
Evaluate the changes in inflammatory cytokines in subjects treated with CRx-102 plus DMARD therapy to placebo plus DMARD therapy.
Evaluate the efficacy of CRx-102 plus DMARD therapy to placebo plus DMARD therapy using ACR-20 and DAS28 indices as well as fatigue scales.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rheumatoid Arthritis, RA, DMARD, CRP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CRx-102 plus DMARD therapy
Arm Type
Experimental
Arm Title
Placebo plus DMARD therapy
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
CRx-102
Other Intervention Name(s)
Prednisolone plus dipyridamole
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
sugar pill
Intervention Type
Drug
Intervention Name(s)
DMARD Therapy
Other Intervention Name(s)
Disease modifying anti-rheumatic drug therapy
Intervention Description
DMARD therapy can include methotrexate or other DMARD therapy
Primary Outcome Measure Information:
Title
Change in CRP From Baseline to Day 42
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
Secondary Outcome Measure Information:
Title
Improvement of ACR 20 Scores at End of Study (Day 42/Visit 5)
Description
The percentage of subjects in each group that achieved an ACR 20 response on Day 42
Time Frame
Day 42
Title
Change in DAS28 Score From Baseline to Day 42
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
Title
Change in Fatigue (MAF Scale) Score From Baseline to Day 42
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).
Convert item #15 to a 0 to 10 scale by multiplying each score by 2.5
Sum items #1, 2, and 3
Average items #4 through 14
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Was 18 years of age of older
Had moderate to severe RA
Had at least 3 swollen joints (maximum 28) and 3 tender joints (maximum 28)
Had a Baseline CRP level of at least 2.2 mg/L and a DAS28 score >4.5
Had been on DMARD therapy for at least 3 months and have been on a stable dose of DMARD therapy for at least 28 days prior to enrollment
Had a negative pregnancy test (females)
Was not taking glucocorticoids at screening
Exclusion Criteria:
Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (barriers or abstinence). Female subjects using hormonal birth control are not to be enrolled.
Subject is currently taking any steroids (glucocorticoids). All glucocorticoids must be discontinued for at least one month prior to entering study. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study.
Subject is currently taking more than 81 mg of aspirin daily.
Subject is currently taking a statin, unless she/he has been on a stable dose of the same statin for at least 3 months prior to entering into the trial.
Subject has any active infections or recent surgical procedures within 30 days of study initiation.
Subject has uncontrolled diabetes mellitus as defined by a HbA1C value ≥ 7.0%.
Subject knowingly has HIV or Hepatitis.
Subject has undergone administration of any investigational drug within 30 days of study initiation.
Subject has a history of hypersensitivity to steroids and/or dipyridamole.
Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Margaret Lee, PhD
Organizational Affiliation
Zalicus
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RA
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