Status:
COMPLETED
Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid Arthritis
Lead Sponsor:
Ionis Pharmaceuticals, Inc.
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 activ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01414101
Start Date
August 1 2011
End Date
May 1 2013
Last Update
May 17 2013
Active Locations (10)
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1
Isis Investigational site
Kamloops, British Columbia, Canada, V2C1K7
2
Isis Investigational Site
Toronto, Ontario, Canada, M9L 3A2
3
Isis Investigational Site
Montreal, Quebec, Canada, 2RV1V6
4
Isis Investigational Site
Moscow, Russia, 109240