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NCT04274257: DesiReS
A Study of the Efficacy and Safety of Rituximab in Participants With Systemic Sclerosis
Completed
Phase 2, PHASE3
Last updated 18 February 2020
What this trial tests
Phase 2, PHASE3 trial testing Double-Blind Placebo in Scleroderma, Systemic in 56 participants. Completed in 5 November 2019.
Timeline
4 December 2017
Primary endpoint
9 May 2019
9 May 2019
5 November 2019
Quick facts
| Lead sponsor | Tokyo University |
|---|---|
| Phase | Phase 2, PHASE3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 56 |
| Start date | 4 December 2017 |
| Primary completion | 9 May 2019 |
| Estimated completion | 5 November 2019 |
| Sites | 4 locations across Japan |
Drugs / interventions tested
- Double-Blind Placebo
- Double-Blind Rituximab — full drug profile →
Conditions studied
- Scleroderma, Systemic — all drugs for Scleroderma, Systemic →
- Skin Sclerosis — all drugs for Skin Sclerosis →
- Lung Fibrosis — all drugs for Lung Fibrosis →
- Autoimmune Diseases — all drugs for Autoimmune Diseases →
Sponsor
Tokyo University
Who can join
Adults 20 to 80, any sex, with Scleroderma, Systemic or Skin Sclerosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study evaluates the efficacy and safety of rituximab compared with placebo in SSc patients. This study consists of a 24-week, double-blind, placebo-controlled period followed by a 24-week active drug treatment period.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Safety and efficacy of rituximab in systemic sclerosis (DESIRES): a double-blind, investigator-initiated, randomised, placebo-controlled trial.
Ebata S, Yoshizaki A, Oba K, Kashiwabara K, et al · · 2021 · cited 194× · PMID 38279402 · DOI 10.1016/s2665-9913(21)00107-7 -
Myofibroblasts: Function, Formation, and Scope of Molecular Therapies for Skin Fibrosis.
Tai Y, Woods EL, Dally J, Kong D, et al · · 2021 · cited 154× · PMID 34439762 · DOI 10.3390/biom11081095 -
Safety and efficacy of rituximab in systemic sclerosis (DESIRES): open-label extension of a double-blind, investigators-initiated, randomised, placebo-controlled trial.
Ebata S, Yoshizaki A, Oba K, Kashiwabara K, et al · · 2022 · cited 45× · PMID 38294008 · DOI 10.1016/s2665-9913(22)00131-x -
Predictors of rituximab effect on modified Rodnan skin score in systemic sclerosis: a machine-learning analysis of the DesiReS trial.
Ebata S, Oba K, Kashiwabara K, Ueda K, et al · · 2022 · cited 28× · PMID 35136981 · DOI 10.1093/rheumatology/keac023 -
Long-term Outcomes After Rituximab Treatment for Patients With Systemic Sclerosis: Follow-up of the DESIRES Trial With a Focus on Serum Immunoglobulin Levels.
Kuzumi A, Ebata S, Fukasawa T, Matsuda KM, et al · · 2023 · cited 23× · PMID 36790794 · DOI 10.1001/jamadermatol.2022.6340 -
Future Treatment Options in Systemic Sclerosis-Potential Targets and Ongoing Clinical Trials.
Bohdziewicz A, Pawlik KK, Maciejewska M, Sikora M, et al · · 2022 · cited 21× · PMID 35268401 · DOI 10.3390/jcm11051310 -
Lysophosphatidic acid receptor 1 inhibition: a potential treatment target for pulmonary fibrosis.
Volkmann ER, Denton CP, Kolb M, Wijsenbeek-Lourens MS, et al · · 2024 · cited 11× · PMID 39009409 · DOI 10.1183/16000617.0015-2024 -
Predictors of rituximab efficacy in systemic sclerosis-associated interstitial lung disease: machine-learning analysis of the DESIRES trial.
Kuzumi A, Oba K, Ebata S, Kashiwabara K, et al · · 2025 · cited 4× · PMID 39718799 · DOI 10.1093/rheumatology/keae716
Verify or expand the search:
- PubMed search for NCT04274257
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Scleroderma, Systemic
Currently open trials in the same condition.
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- NCT05878717 — A Study of the Efficacy and Safety of Belimumab in Adults With Systemic Sclerosis Associated Interstitial Lung Disease · Phase 2, PHASE3 · recruiting
- NCT07345052 — Western Sweden Systemic Sclerosis Project · recruiting
Other Tokyo University trials
Trials by the same sponsor.
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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)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT04274257 (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 Tokyo University
- Last refreshed: 18 February 2020
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/NCT04274257.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing