NCT03332719 (GEMENE) is a Phase 3 clinical trial of Etanercept in Rheumatoid Arthritis, sponsored by Gema Biotech S.A..

Who is sponsoring NCT03332719?

NCT03332719 is sponsored by Gema Biotech S.A..

What drugs are being tested in NCT03332719?

Interventions in NCT03332719: Etanercept, Methotrexate.

What condition does NCT03332719 study?

NCT03332719 studies Rheumatoid Arthritis.

Is NCT03332719 still recruiting?

NCT03332719 is currently completed. Last updated 1 November 2017.

Last reviewed 2017-11-01 · How we verify

NCT03332719: GEMENE

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

Multicentric Evaluator-blinded Randomized Non-inferiority Study, to Asses the Compared Efficacy, Safety and Immunogenicity of Enerceptan® With Enbrel® in Combination With Methotrexate for the Treatment of Patients With Rheumatoid Arthritis

Completed Phase 3 Last updated 1 November 2017

What this trial tests

Phase 3 trial testing Etanercept in Rheumatoid Arthritis in 168 participants. Completed in 1 September 2017.

Timeline

1 February 2016

Primary endpoint
1 March 2017

1 September 2017

Quick facts

Lead sponsor	Gema Biotech S.A.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	168
Start date	1 February 2016
Primary completion	1 March 2017
Estimated completion	1 September 2017
Sites	1 location across Argentina

Drugs / interventions tested

Etanercept (etanercept) — full drug profile →
Methotrexate — full drug profile →

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

Gema Biotech S.A. — full company profile →

Who can join

Adults 19 to 99, 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.

ACR (American College of Rheumatology) 20
Time frame: 32 weeks of treatment
The percentage of patients who achieved ACR20 at Week 32 is the primary end point. Signs and symptoms are assessed with a composite rating scale of the ACR (American College of Rheumatology) that includes 7 variables: * Tender Joints Count * Swollen Joints Count * Levels of an acute phase reactant (CRP level) * Patient's assessment of pain * Patient's global assessment of disease activity * Phys

Sponsor's own description

The purpose of this study is to asses the compared efficacy, safety and immunogenicity of ENERCEPTAN® with ENBREL® in combination with Methotrexate for the treatment of patients with rheumatoid arthritis.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy, safety and immunogenicity of etanercept biosimilars <i>versus</i> reference biologics in patients with rheumatoid arthritis: A meta-analysis.
Hu R, Yuan T, Wang H, Zhao J, et al · · 2023 · cited 8× · PMID 36874005 · DOI 10.3389/fphar.2023.1089272

Verify or expand the search:

Other trials of Etanercept

Trials testing the same drug.

NCT06016517 — Application of the Personalized N-of-1 Trial Design in Patients With Rheumatoid Arthritis · not yet recruiting
NCT07352566 — Utilization of a Microdevice for Psoriasis and Atopic Dermatitis · Phase 4 · not yet recruiting
NCT06707194 — Effect and Safety of Benzathine Penicillin Combined With Etanercept on Spondyloarthritis · Phase 4 · recruiting
NCT06011889 — Study of the Efficacy and Safety of Etanercept Treatment in Patients With SAPHO Syndrome · Phase 2, PHASE3 · recruiting
NCT05281614 — Immune Effects of Vedolizumab With or Without Anti-TNF Pre-treatment in T1D · EARLY_PHASE1 · completed

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 Gema Biotech S.A. trials

Trials by the same sponsor.

NCT03403140 — Long Term Efficacy, Safety and Immunogenicity of Enerceptan in Rheumatoid Arthritis ( GEMENE002 ) · Phase 3 · unknown

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 NCT03332719 (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 Gema Biotech S.A.
Last refreshed: 1 November 2017

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/NCT03332719.

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