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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRx-102 plus DMARD therapy | Experimental |
| |
| Placebo plus DMARD therapy | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRx-102 | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and Day 42 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 42 |
| Change in DAS28 Score From Baseline to Day 42 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret Lee, PhD | Zalicus | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | CRx-102 Plus DMARD Therapy | 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) |
| FG001 | Placebo Plus DMARD Therapy | Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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.
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| ID | Title | Description |
|---|---|---|
| BG000 | CRx-102 Plus DMARD Therapy | 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) |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | percentage change from baseline | Baseline and Day 42 |
|
8 weeks: from screening (visit 1) up to 14 days prior to baseline (visit 2) through end of study (visit 5) on day 42.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CRx-102 Plus DMARD Therapy | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| femoral hernia | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment | Left femoral hernia that required hospitalization and surgical correction. In the opinion of the investigator this event was not related to study drug. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Margaret Lee, PhD | Zalicus | 617-301-7142 | mlee@zalicus.com |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| C530511 | dipyridamole, prednisolone drug combination |
| D011239 | Prednisolone |
| D004176 | Dipyridamole |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Drug |
|
|
| DMARD Therapy | Drug | DMARD therapy can include methotrexate or other DMARD therapy |
|
|
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.
| Baseline and Day 42 |
| 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).
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. | Baseline and Day 42 |
| Placebo Plus DMARD Therapy |
Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy
|
|
| Secondary | 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 | Posted | Number | percentage of participants | Day 42 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 42 |
|
|
|
| Secondary | 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).
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. | Posted | Mean | Standard Deviation | units on a scale | Baseline and Day 42 |
|
|
|
| 0 |
| 27 |
| 20 |
| 27 |
| EG001 | Placebo Plus DMARD Therapy | Daily oral treatment with placebo, dosed twice per day (8AM and 1 PM) plus stable dose of DMARD therapy | 1 | 32 | 13 | 32 |
|
| Nausea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Rheumatoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
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| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002241 | Carbohydrates |