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NCT01414101

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

Completed Phase 2 Last updated 16 May 2013
What this trial tests

Phase 2 trial testing ISIS CRP Rx or Placebo in Rheumatoid Arthritis in 51 participants. Completed in 1 May 2013.

Timeline
1 August 2011
Primary endpoint
1 May 2013
1 May 2013

Quick facts

Lead sponsorIonis Pharmaceuticals, Inc.
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment51
Start date1 August 2011
Primary completion1 May 2013
Estimated completion1 May 2013
Sites10 locations across Canada, Russia

Drugs / interventions tested

Conditions studied

Sponsor

Ionis Pharmaceuticals, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A novel phosphocholine-mimetic inhibits a pro-inflammatory conformational change in C-reactive protein.
    Zeller J, Cheung Tung Shing KS, Nero TL, McFadyen JD, et al · · 2023 · cited 43× · PMID 36468184 · DOI 10.15252/emmm.202216236
  2. 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.
    Warren MS, Hughes SG, Singleton W, Yamashita M, et al · · 2015 · cited 21× · PMID 25885521 · DOI 10.1186/s13075-015-0578-5

Verify or expand the search:

Other recruiting trials for Rheumatoid Arthritis

Currently open trials in the same condition.

Other Ionis Pharmaceuticals, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01414101.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing