Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Drug: ISIS CRP Rx or Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Dose 1 ISIS CRP Rx versus Placebo | Drug: ISIS CRP Rx or Placebo<br> <br> |
| Experimental: Group B<br>Dose 2 ISIS CRP Rx versus Placebo | Drug: ISIS CRP Rx or Placebo<br> <br> |
| Experimental: Group C<br>Dose 3 ISIS CRP Rx versus Placebo | Drug: ISIS CRP Rx or Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Adverse events, laboratory tests, and vital signs | 155 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hsCRP | The effects of treatment with ISIS CRP Rx or Placebo on hsCRP | 155 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rheumatoid Arthritis