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

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01414101
• Other study ID #: ISIS 329993-CS3
• Status: Completed
• Phase: Phase 2
• First received: July 21, 2011
• Last updated: May 16, 2013
• Start date: August 2011
• Est. completion date: May 2013

Study information

• Verified date: May 2013
• Source: Ionis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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 active rheumatoid arthritis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• ISIS CRP Rx or Placebo

Locations

Country	Name	City	State
Canada	Isis Investigational site	Kamloops	British Columbia
Canada	Isis Investigational Site	Montreal	Quebec
Canada	Isis Investigational Site	Toronto	Ontario
Russian Federation	Isis Investigational Site	Moscow
Russian Federation	Isis Investigational Site	Moscow
Russian Federation	Isis Investigational Site	Moscow
Russian Federation	Isis Investigational Site	Saint Petersburg
Russian Federation	Isis Investigational Site	Saint Petersburg
Russian Federation	Isis Investigational Site	Saint Petersburg
Russian Federation	Isis Investigational Site	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Ionis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

Canada,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Adverse events, laboratory tests, and vital signs	155 Days	Yes
Secondary	hsCRP	The effects of treatment with ISIS CRP Rx or Placebo on hsCRP	155 Days	No