NCT02837978 is a Phase 4 clinical trial of Tacrolimus in Arthritis, Rheumatoid, sponsored by Qiang Shu.

Who is sponsoring NCT02837978?

NCT02837978 is sponsored by Qiang Shu.

What drugs are being tested in NCT02837978?

Interventions in NCT02837978: Tacrolimus, MTX.

What condition does NCT02837978 study?

NCT02837978 studies Arthritis, Rheumatoid.

Is NCT02837978 still recruiting?

NCT02837978 is currently completed. Last updated 16 November 2023.

Last reviewed 2023-11-16 · How we verify

NCT02837978

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Prospective Clinical Study to Observe the Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months Treatment in China

Completed Phase 4 Last updated 16 November 2023

What this trial tests

Phase 4 trial testing Tacrolimus in Arthritis, Rheumatoid in 150 participants. Completed in 30 December 2022.

Timeline

1 January 2015

Primary endpoint
30 September 2022

30 December 2022

Quick facts

Lead sponsor	Qiang Shu
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	150
Start date	1 January 2015
Primary completion	30 September 2022
Estimated completion	30 December 2022
Sites	1 location across China

Drugs / interventions tested

Tacrolimus (TACROLIMUS) — full drug profile →
MTX — full drug profile →

Conditions studied

Arthritis, Rheumatoid — all drugs for Arthritis, Rheumatoid →

Sponsor

Qiang Shu

Who can join

Adults 18 to 80, any sex, with Arthritis, Rheumatoid. 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.

Change from baseline Disease Activity Score 28 (DAS28-ESR) at 24 and longer weeks.
Time frame: 12 week, 24week,36 week,48 week,72 week,96 week,120 week,144 week
Change from baseline Disease Activity Score 28 (DAS28) erythrocyte sedimentation rate (ESR) at 24 and longer weeks.

Sponsor's own description

This study is designed to observed prospectively the efficacy and safety of 6 months and long-term treatment of Tacrolimus alone or with methotrexate (MTX) in moderate and severe Chinese RA patients who shown insufficiency response or intolerance to DMARDs

Publications & conference data

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

Calcineurin-NFAT signalling in myeloid leucocytes: new prospects and pitfalls in immunosuppressive therapy.
Bendickova K, Tidu F, Fric J. · · 2017 · cited 52× · PMID 28606994 · DOI 10.15252/emmm.201707698
Galectin-9 expression correlates with therapeutic effect in rheumatoid arthritis.
Sun J, Sui Y, Wang Y, Song L, et al · · 2021 · cited 22× · PMID 33692448 · DOI 10.1038/s41598-021-85152-2

Verify or expand the search:

Other trials of Tacrolimus

Trials testing the same drug.

NCT07519174 — A Randomized Controlled Trial Comparing the Effectiveness and Safety of Topical Tacrolimus 0.03% Versus Crisaborole 2% i · NA · not yet recruiting
NCT07249346 — Dose-Expansion Study of Low Dose Post-Transplant Cyclophosphamide/Tacrolimus/Ruxolitinib for Graft-versus-Host Disease ( · Phase 2 · recruiting
NCT07349771 — Axatilimab Plus Standard of Care Therapy for the Prevention of Graft Versus Host Disease Following Allogeneic Hematopoie · Phase 2 · not yet recruiting
NCT06996119 — Emapalumab With Post-Transplant Cyclophosphamide, Tacrolimus and Mycophenolate Mofetil for the Prevention of Graft-versu · Phase 1 · not yet recruiting
NCT07566377 — Cord Blood Transplantation in Children and Young Adults With Blood Cancer · Phase 2 · recruiting

Other recruiting trials for Arthritis, Rheumatoid

Currently open trials in the same condition.

NCT07176390 — A Clinical Study of Tulisokibart (MK-7240) to Treat Rheumatoid Arthritis (RA) (MK-7240-014) · Phase 2 · recruiting
NCT06842316 — Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases · recruiting
NCT06528431 — Design and Evaluation of an Individualized Biodrug Tapering Strategy Based on Biodrug Dosage: the MONITORA Study · Phase 4 · recruiting
NCT06492200 — Impact of a High-fiber Diet on the Microbiome and Disease Activity in Patients With Rheumatoid Arthritis · NA · recruiting
NCT06246123 — A Study of Jyseleca Tablet (Filgotinib Maleate) in Korean Participants · recruiting

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 NCT02837978 (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 Qiang Shu
Last refreshed: 16 November 2023

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/NCT02837978.

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