RA rheumatoid arthritis
Conditions
Interventions
Subjects will take 2 tablets in the morning (study drug or placebo) and 1
tablet in the evening (study drug or placebo).
Sponsors
Chemocentryx
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Male or female subjects, aged 18-75 years inclusive, with functional class I to III RA based on ACR criteria for at least 3 months prior to screening; wheel-chair bound subjects or those with irreversible disease will not be eligible 2. Subjects must have active RA, defined by a minimum of 8 swollen joints and 8 tender/painfull joints (based on 66/68 joint count), at screening 3. Serum C-reactive protein (CRP) above 5 mg/L at screening 4. Must have been on methotrexate (7.5 to 25 mg/week) taken orally, subcutaneously, or intramuscularly for * 16 weeks and on a stable dose for * 8 weeks prior to randomization. 5. If on hydroxychloroquine, must have been on a stable dose for * 16 weeks prior to randomization 6. If taking non-steroidal anti-inflammatory drugs (NSAIDs), must have been on stable doses for * 2 weeks before randomization 7. If taking oral corticosteroids, subjects may not take more than 10 mg/day of prednisone or equivalent, and must have been on a stable dose for * 4 weeks before randomization. For more inclusion criteria, please refer to protocol.
Exclusion criteria
Exclusion criteria: 1. Diagnosed with RA prior to 16 years of age 2. Women who are pregnant, breastfeeding, or have a positive serum pregnancy test at screening 3. History within one year prior to randomization of illicit drug use 4. History of alcohol abuse at any time in the past 5. Have received sulfasalazine, azathioprine, 6-mercaptopurine, mycophenolate mofetil, tetracycline, cyclosporine, gold, tacrolimus, sirolimus, or other disease modifying anti-rheumatic drug (DMARD) within 8 weeks of randomization; 6. Use of infliximab, adalimumab, abatacept, certolizumab, golimumab, or tocilizumab within 8 weeks of randomization 7. Use of leflunomide within 6 months of randomization 8. Use of etanercept or anakinra within 4 weeks of randomization 9. Use of a B-cell depleting agent such as rituximab or ocrelizumab, or cytotoxic agents, such as cyclophosphamide or chlorambucil, within one year of randomization. For more exclusion criteria, please refer to protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary safety endpoint is the subject incidence of adverse events. The main efficacy endpoints include: 1. Change from baseline to Week 12 in DAS28-CRP. 2. ACR20, ACR50, and ACR70 Response at Week 12. 3. Proportion of subjects achieving a DAS28-CRP score less than 2.6 (remission) at Week 12. 4. Proportion of subjects achieving a DAS28-CRP score less than 3.2 (low disease activity) at Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other safety endpoints include: 1. Subject incidence of serious adverse events 2. Subject incidence of withdrawals due to adverse events 3. Change from baseline in all safety laboratory parameters 4. Change from baseline in vital signs 5. Clinically significant ECG abnormalities. Other efficacy endpoints include: 1. Proportion of subjects achieving the MCID of 0.22 in HAQ-DI at Week 12. 2. Change from baseline to Week 12 in the components of the DAS28 and ACR, including the swollen joint count, the tender/painful joint count, the subject*s assessment of RA (VAS), the subject*s assessment of pain (VAS), the physician*s assessment of the subject*s RA (VAS), the HAQ-DI, CRP, and ESR. 3. Change from baseline to Week 12 in DAS28-ESR. 4. Change from baseline to Week 12 in duration of morning stiffness. | — |
Countries
Netherlands
Outcome results
None listed