Rheumatoid Arthritis Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Phase 2 Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ISIS 329993 in Subjects With Rheumatoid Arthritis
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ISIS CRP Rx and its effects on CRP and other pharmacodynamic measures, versus placebo, in subjects with active rheumatoid arthritis.
Status | Completed |
Enrollment | 51 |
Est. completion date | May 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Male or female; age 18 to 75 years - Active RA for at least 6 months - Active disease defined by having equal to or greater than 6 swollen joints and 6 tender joints, based on a 28 joint count - On stable doses and regimen of allowed RA medications - Currently receiving at least 10 mg of methotrexate a week. Patients unable to tolerate doses greater than 10 mg may also be eligible for enrollment. Exclusion Criteria: - Diagnosis of Felty's syndrome, psoriatic arthritis, gout, or auto-immune rheumatic disease - Any surgical procedure within 30 days of Screening or likely to need joint or tendon surgery or other surgical procedure during the study - Intra-articular or intra-muscular corticosteroids within 60 days prior to dosing - Previous treatment with any biologic response modifying agent for RA within 90 days or 5 half-lives, whichever is greater, prior to screening - Previous treatment with rituximab at any time - Use of corticosteroid therapy equivalent to an average daily dose of >10 mg of prednisone - Any Screening laboratory values that are out of allowed reference ranges - Inability to comply with protocol or study procedures - Any other significant illness or condition that may adversely affect the subjects participation in the study |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Isis Investigational site | Kamloops | British Columbia |
Canada | Isis Investigational Site | Montreal | Quebec |
Canada | Isis Investigational Site | Toronto | Ontario |
Russian Federation | Isis Investigational Site | Moscow | |
Russian Federation | Isis Investigational Site | Moscow | |
Russian Federation | Isis Investigational Site | Moscow | |
Russian Federation | Isis Investigational Site | Saint Petersburg | |
Russian Federation | Isis Investigational Site | Saint Petersburg | |
Russian Federation | Isis Investigational Site | Saint Petersburg | |
Russian Federation | Isis Investigational Site | Saint Petersburg |
Lead Sponsor | Collaborator |
---|---|
Ionis Pharmaceuticals, Inc. |
Canada, Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety | Adverse events, laboratory tests, and vital signs | 155 Days | Yes |
Secondary | hsCRP | The effects of treatment with ISIS CRP Rx or Placebo on hsCRP | 155 Days | No |
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