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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
Phase 2 trial testing ISIS CRP Rx or Placebo in Rheumatoid Arthritis in 51 participants. Completed in 1 May 2013.
1 May 2013
Quick facts
| Lead sponsor | Ionis Pharmaceuticals, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 51 |
| Start date | 1 August 2011 |
| Primary completion | 1 May 2013 |
| Estimated completion | 1 May 2013 |
| Sites | 10 locations across Canada, Russia |
Drugs / interventions tested
- ISIS CRP Rx or Placebo — full drug profile →
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
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.
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Safety
Time frame: 155 Days
Adverse events, laboratory tests, and vital signs
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):
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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 -
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:
- PubMed search for NCT01414101
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Rheumatoid Arthritis
Currently open trials in the same condition.
- NCT07433335 — A Study to Assess the Safety and Tolerability of SR-878 in Patients With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07491016 — Efficacy and Safety of Telitacicept Combined With Baricitinib for Refractory Rheumatoid Arthritis · recruiting
- NCT07171983 — A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986454 in Participants With Rheumatoid Arthritis · Phase 1 · recruiting
- NCT07246096 — Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19/BCMA U CAR-T Cell Injection for the Treatment of Rel · EARLY_PHASE1 · recruiting
- NCT07363590 — A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004) · Phase 1 · recruiting
Other Ionis Pharmaceuticals, Inc. trials
Trials by the same sponsor.
- NCT06673069 — Hero: A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) and Pharmacodynamics (PD) of ION269 in Par · Phase 1 · terminated
- NCT06014541 — Observational Study to Characterize Biomarkers and Disease Progression in Participants With Methyl CpG Binding Protein 2 · terminated
- NCT05610280 — A Study of Olezarsen (ISIS 678354) in Participants With Hypertriglyceridemia and Atherosclerotic Cardiovascular Disease, · Phase 3 · completed
- NCT05579860 — A Study Comparing Two Subcutaneous Formulations: Vial and Autoinjector (AI) With Olezarsen, at Two Dose Levels, in Healt · Phase 1 · completed
- NCT05552326 — A Study of Olezarsen Administered Subcutaneously to Participants With Severe Hypertriglyceridemia · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01414101 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ionis Pharmaceuticals, Inc.
- Last refreshed: 16 May 2013
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