Trial reportArthritis research & therapy2015
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.
Trial report in Arthritis research & therapy, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial 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), which is not on this map. Cited by 19 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
19 citing papers in PubMed, 24 citations in OpenAlex.
- Meta-analysis of adverse events in clinical studies with antisense oligonucleotide therapies.Molecular therapy. Nucleic acids · 2026Review
- CRP (C-Reactive Protein) Revisited: An Old Yet New Biomarker of Acute and Chronic Inflammation.Cells · 2026Review
- A novel lncRNA, Lnc21q22.11, suppresses gastric cancer growth by inhibiting MEK/ERK pathway.Epigenetics · 2025Article
- Pre-Percutaneous Coronary Intervention C-Reactive Protein Levels and In-Stent Restenosis: A Systematic Review and Meta-Analysis.Health science reports · 2025Review
- The Potential Role of C-Reactive Protein in Metabolic-Dysfunction-Associated Fatty Liver Disease and Aging.Biomedicines · 2023Review
- Effects of C-reactive protein trajectories of critically ill patients with sepsis on in-hospital mortality rate.Scientific reports · 2023Review
- Being Eaten Alive: How Energy-Deprived Cells Are Disposed of, Mediated by C-Reactive Protein-Including a Treatment Option.Biomedicines · 2023Article
- Monomeric C-Reactive Protein in Atherosclerotic Cardiovascular Disease: Advances and Perspectives.International journal of molecular sciences · 2023Review
- Targeting conformational changes in C-reactive protein to inhibit pro-inflammatory actions.EMBO molecular medicine · 2023Article
- A novel phosphocholine-mimetic inhibits a pro-inflammatory conformational change in C-reactive protein.EMBO molecular medicine · 2023Article
- C-reactive protein: a target for therapy to reduce inflammation.Frontiers in immunology · 2023Review
- Noncoding RNA therapeutics - challenges and potential solutions.Nature reviews. Drug discovery · 2021Review
- Anti-Rheumatic Effect of Antisense Oligonucleotide Cytos-11 Targeting TNF-α Expression.International journal of molecular sciences · 2021Article
- Precision multiparameter tracking of inflammation on timescales of hours to years using serial dried blood spots.Bioanalysis · 2020Article
- Therapeutic Lowering of C-Reactive Protein.Frontiers in immunology · 2020Review
- RNA Therapeutics in Cardiovascular Precision Medicine.Frontiers in physiology · 2018Review
- Therapeutic approaches targeting inflammation for diabetes and associated cardiovascular risk.The Journal of clinical investigation · 2017Review
- Long noncoding RNA expression profile in fibroblast-like synoviocytes from patients with rheumatoid arthritis.Arthritis research & therapy · 2016Article
- Integrated Safety Assessment of 2'-O-Methoxyethyl Chimeric Antisense Oligonucleotides in NonHuman Primates and Healthy Human Volunteers.Molecular therapy : the journal of the American Society of Gene Therapy · 2016Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThis randomized, double-blind, phase II study evaluated the pharmacodynamics, safety and tolerability of ISIS 329993 (ISIS-CRPRx), an antisense oligonucleotide, in patients with active rheumatoid arthritis (RA).
methodsPatients with active RA of at least six months duration were randomized into three cohorts to receive ISIS-CRPRx (100 mg, 200 mg or 400 mg) or placebo (3 active:1 placebo within each cohort) via subcutaneous (SC) injection on Days 1, 3, 5 and 8 and then once weekly for the next 11 weeks. The effects of study treatment on high-sensitivity C-reactive protein (hs-CRP) level were evaluated. An exploratory analysis on disease activity was assessed via the American College of Rheumatology 20% improvement criteria (ACR20). Safety was evaluated via adverse events and laboratory measures.
resultsFifty-one patients received one of the following treatments: ISIS-CRPRx 100 mg, n = 12; 200 mg, n = 13, 400 mg, n = 14; placebo n = 12. In the ISIS-CRPRx treatment groups there were dose-dependent reductions in hs-CRP. At Day 36 the mean percent change from baseline was: placebo: -14.4%; ISIS-CRPRx 100 mg: -19.5%; 200 mg: -56.6% and 400 mg: -76.7%, (P = 0.0015 placebo compared to 400 mg). There were no differences between treatment groups and placebo in the ACR20 at Day 36 or Day 92. There were no serious infections and no elevations in liver function tests, lipids, creatinine or other lab abnormalities related to ISIS-CRPRx.
conclusionsIn this study, ISIS-CRPRx selectively reduced hs-CRP in a dose-dependent manner, and was well-tolerated in patients with RA. Its utility as a therapy in RA remains unclear.
trial registrationClinicaltrials.gov NCT01414101 . Registered 21 July 2011.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.