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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-05-31

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.

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Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Group A

Dose 1 ISIS CRP Rx versus Placebo

Group Type EXPERIMENTAL

ISIS CRP Rx or Placebo

Intervention Type DRUG

Group B

Dose 2 ISIS CRP Rx versus Placebo

Group Type EXPERIMENTAL

ISIS CRP Rx or Placebo

Intervention Type DRUG

Group C

Dose 3 ISIS CRP Rx versus Placebo

Group Type EXPERIMENTAL

ISIS CRP Rx or Placebo

Intervention Type DRUG

Interventions

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ISIS CRP Rx or Placebo

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No