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NCT01679951
A Dose Range Finding Study of JNJ-38518168 in Patients With Active Rheumatoid Arthritis in Spite of Treatment With Methotrexate
Phase 2 trial testing Placebo in Rheumatoid Arthritis in 272 participants. Terminated before completion.
17 April 2014
Quick facts
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 272 |
| Start date | 31 October 2012 |
| Primary completion | 17 April 2014 |
| Estimated completion | 3 July 2014 |
| Sites | 85 locations across Colombia, Japan, Russia, Ukraine, Chile, Taiwan, Hungary, Mexico |
Drugs / interventions tested
- Placebo
- JNJ-38518168 (3 mg)
- JNJ-38518168 (10 mg)
- JNJ-38518168 (30 mg)
- Methotrexate — full drug profile →
Conditions studied
- Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →
Sponsor
Janssen Research & Development, LLC — full company profile →
Who can join
Adults 18 to 80, any sex, with Rheumatoid Arthritis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this dose range finding study is to assess the effectiveness, safety and tolerability of JNJ-38518168 at doses of 3, 10, and 30 mg/d compared with placebo in patients with active rheumatoid arthritis (RA) despite concomitant methotrexate (MTX) therapy.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
The Role of Histamine and Histamine Receptors in Mast Cell-Mediated Allergy and Inflammation: The Hunt for New Therapeutic Targets.
Thangam EB, Jemima EA, Singh H, Baig MS, et al · · 2018 · cited 347× · PMID 30150993 · DOI 10.3389/fimmu.2018.01873 -
The histamine H4 receptor: from orphan to the clinic.
Thurmond RL. · · 2015 · cited 85× · PMID 25873897 · DOI 10.3389/fphar.2015.00065 -
Histamine H₄ receptors in the gastrointestinal tract.
Deiteren A, De Man JG, Pelckmans PA, De Winter BY. · · 2015 · cited 45× · PMID 25363289 · DOI 10.1111/bph.12989 -
New antihistamines - perspectives in the treatment of some allergic and inflammatory disorders.
Tatarkiewicz J, Rzodkiewicz P, Żochowska M, Staniszewska A, et al · · 2019 · cited 19× · PMID 30899308 · DOI 10.5114/aoms.2017.68534 -
Enigmatic Histamine Receptor H<sub>4</sub> for Potential Treatment of Multiple Inflammatory, Autoimmune, and Related Diseases.
Mehta P, Miszta P, Rzodkiewicz P, Michalak O, et al · · 2020 · cited 18× · PMID 32344736 · DOI 10.3390/life10040050 -
Targeting histamine receptor 4 in cholinergic urticaria with izuforant (LEO 152020): results from a phase IIa randomized double-blind placebo-controlled multicentre crossover trial.
Grekowitz E, Metz M, Altrichter S, Bauer A, et al · · 2024 · cited 4× · PMID 38308655 · DOI 10.1093/bjd/ljae038
Verify or expand the search:
- PubMed search for NCT01679951
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Janssen Research & Development, LLC trials
Trials by the same sponsor.
- NCT07518186 — A Study Comparing JNJ-79635322 and Teclistamab in Participants With Relapsed or Refractory Multiple Myeloma · Phase 3 · not yet recruiting
- NCT07309445 — A Study to Assess Real-World Use and Outcomes of TAR-200 for Participants With Non-Muscle Invasive Bladder Cancer (NMIBC · recruiting
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- NCT07438496 — A Study of Nipocalimab in Adults With Moderate to Severe Systemic Lupus Erythematosus · Phase 3 · recruiting
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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 NCT01679951 (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 Janssen Research & Development, LLC
- Last refreshed: 18 March 2019
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/NCT01679951.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing