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

Phase 2

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: ISIS CRP Rx or Placebo

• Registration Number: NCT01414101
• Lead Sponsor: Ionis Pharmaceuticals, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-07-21
• Study Start: 2011-08
• Study First Submitted QC: 2011-08-09
• Study First Posted: 2011-08-11
• Status Verified: 2013-05
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Last Update Submitted: 2013-05-16
• Last Update Posted: 2013-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	ISIS CRP Rx or Placebo	Dose 1 ISIS CRP Rx versus Placebo
Group B	ISIS CRP Rx or Placebo	Dose 2 ISIS CRP Rx versus Placebo
Group C	ISIS CRP Rx or Placebo	Dose 3 ISIS CRP Rx versus Placebo

Primary Outcome Measures

Name	Time	Method
Safety	155 Days	Adverse events, laboratory tests, and vital signs

Secondary Outcome Measures

Name	Time	Method
hsCRP	155 Days	The effects of treatment with ISIS CRP Rx or Placebo on hsCRP

Trial Locations

Locations (2)

Isis Investigational Site; 🇷🇺 Saint Petersburg, Russian Federation

Isis Investigational site; 🇨🇦 Kamloops, British Columbia, Canada