NCT01414101

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at below P25 for phase_2 rheumatoid-arthritis

Timeline
Completed

Started Aug 2011

Geographic Reach
2 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2011

Completed
11 days until next milestone

Study Start

First participant enrolled

August 1, 2011

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 11, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

May 17, 2013

Status Verified

May 1, 2013

Enrollment Period

1.8 years

First QC Date

July 21, 2011

Last Update Submit

May 16, 2013

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • Safety

    Adverse events, laboratory tests, and vital signs

    155 Days

Secondary Outcomes (1)

  • hsCRP

    155 Days

Study Arms (3)

Group A

EXPERIMENTAL

Dose 1 ISIS CRP Rx versus Placebo

Drug: ISIS CRP Rx or Placebo

Group B

EXPERIMENTAL

Dose 2 ISIS CRP Rx versus Placebo

Drug: ISIS CRP Rx or Placebo

Group C

EXPERIMENTAL

Dose 3 ISIS CRP Rx versus Placebo

Drug: ISIS CRP Rx or Placebo

Interventions

ISIS CRP Rx or PlaceboDRUG
Group AGroup BGroup C

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Isis Investigational site

Kamloops, British Columbia, V2C1K7, Canada

Location

Isis Investigational Site

Toronto, Ontario, M9L 3A2, Canada

Location

Isis Investigational Site

Montreal, Quebec, 2RV1V6, Canada

Location

Isis Investigational Site

Moscow, 109240, Russia

Location

Isis Investigational Site

Moscow, 115522, Russia

Location

Isis Investigational Site

Moscow, 121374, Russia

Location

Isis Investigational Site

Saint Petersburg, 191104, Russia

Location

Isis Investigational Site

Saint Petersburg, 196247, Russia

Location

Isis Investigational Site

Saint Petersburg, 197022, Russia

Location

Isis Investigational Site

Saint Petersburg, 199106, Russia

Location

Related Publications (1)

  • 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.

    PMID: 25885521DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

ISIS 329993

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2011

First Posted

August 11, 2011

Study Start

August 1, 2011

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

May 17, 2013

Record last verified: 2013-05

Locations

RU(7)CA(3)