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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Isis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01414101
First received: July 21, 2011
Last updated: May 16, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: ISIS CRP Rx or Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Isis Pharmaceuticals:

Primary Outcome Measures:
  • Safety [ Time Frame: 155 Days ] [ Designated as safety issue: Yes ]
    Adverse events, laboratory tests, and vital signs


Secondary Outcome Measures:
  • hsCRP [ Time Frame: 155 Days ] [ Designated as safety issue: No ]
    The effects of treatment with ISIS CRP Rx or Placebo on hsCRP


Enrollment: 51
Study Start Date: August 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01414101

Locations
Canada, British Columbia
Isis Investigational site
Kamloops, British Columbia, Canada, V2C1K7
Canada, Ontario
Isis Investigational Site
Toronto, Ontario, Canada, M9L 3A2
Canada, Quebec
Isis Investigational Site
Montreal, Quebec, Canada, 2RV1V6
Russian Federation
Isis Investigational Site
Moscow, Russian Federation, 115522
Isis Investigational Site
Moscow, Russian Federation, 121374
Isis Investigational Site
Moscow, Russian Federation, 109240
Isis Investigational Site
Saint Petersburg, Russian Federation, 199106
Isis Investigational Site
Saint Petersburg, Russian Federation, 191104
Isis Investigational Site
Saint Petersburg, Russian Federation, 197022
Isis Investigational Site
Saint Petersburg, Russian Federation, 196247
Sponsors and Collaborators
Isis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Isis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01414101     History of Changes
Other Study ID Numbers: ISIS 329993-CS3
Study First Received: July 21, 2011
Last Updated: May 16, 2013
Health Authority: Canada: Health Canada
Russia: Ministry of Health of the Russian Federation

Keywords provided by Isis Pharmaceuticals:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014