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

May 16, 2013 updated by: Ionis Pharmaceuticals, Inc.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Kamloops, British Columbia, Canada, V2C1K7
        • Isis Investigational Site
    • Ontario
      • Toronto, Ontario, Canada, M9L 3A2
        • Isis Investigational Site
    • Quebec
      • Montreal, Quebec, Canada, 2RV1V6
        • Isis Investigational Site
  • Russian Federation
      • Moscow, Russian Federation, 109240
        • Isis Investigational Site
      • Moscow, Russian Federation, 115522
        • Isis Investigational Site
      • Moscow, Russian Federation, 121374
        • Isis Investigational Site
      • Saint Petersburg, Russian Federation, 191104
        • Isis Investigational Site
      • Saint Petersburg, Russian Federation, 196247
        • Isis Investigational Site
      • Saint Petersburg, Russian Federation, 197022
        • Isis Investigational Site
      • Saint Petersburg, Russian Federation, 199106
        • Isis Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ionis Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 21, 2011

First Submitted That Met QC Criteria

August 9, 2011

First Posted (Estimate)

August 11, 2011

Study Record Updates

Last Update Posted (Estimate)

May 17, 2013

Last Update Submitted That Met QC Criteria

May 16, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISIS 329993-CS3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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