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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01414101

Enrollment

Registered

2011-08-11

Start date

2011-08-31

Completion date

2013-05-31

Last updated

2013-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

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.

Interventions

DRUGISIS CRP Rx or Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Safety	155 Days	Adverse events, laboratory tests, and vital signs

Secondary

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

Countries

Canada, Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026