Clinical trial NCT01414101: Safety, Tolerability, and Pharmacodynamic Study of ISIS CRP Rx in Rheumatoid Arthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2011-08-11
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Safety
timeFrame: 155 Days
Secondary outcomes:
measure: hsCRP
timeFrame: 155 Days
Other outcomes:
Locations:
city: Kamloops
country: Canada
facility: Isis Investigational site
state: British Columbia
city: Toronto
country: Canada
facility: Isis Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: Isis Investigational Site
state: Quebec
city: Moscow
country: Russian Federation
facility: Isis Investigational Site
city: Moscow
country: Russian Federation
facility: Isis Investigational Site
city: Moscow
country: Russian Federation
facility: Isis Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Isis Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Isis Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Isis Investigational Site
city: Saint Petersburg
country: Russian Federation
facility: Isis Investigational Site
Study officials:
References:
citation: Warren MS, Hughes SG, Singleton W, Yamashita M, Genovese MC. Results of a proof of concept, double-blind, randomized trial of a second generation antisense oligonucleotide targeting high-sensitivity C-reactive protein (hs-CRP) in rheumatoid arthritis. Arthritis Res Ther. 2015 Mar 19;17(1):80. doi: 10.1186/s13075-015-0578-5.