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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
Zalicus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rheumatoid Arthritis, RA, DMARD, CRP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 3, 2008
    Last Updated
    April 22, 2014
    Sponsor
    Zalicus
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    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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