NCT01793259 is a Phase 3 clinical trial of methotrexate prefilled pen in Rheumatoid Arthritis, sponsored by medac GmbH.

Who is sponsoring NCT01793259?

NCT01793259 is sponsored by medac GmbH.

What drugs are being tested in NCT01793259?

Interventions in NCT01793259: methotrexate prefilled pen, methotrexate prefilled syringe.

What condition does NCT01793259 study?

NCT01793259 studies Rheumatoid Arthritis.

Is NCT01793259 still recruiting?

NCT01793259 is currently completed. Last updated 12 July 2013.

Last reviewed 2013-07-12 · How we verify

NCT01793259

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

An Open-label, Randomized, Two-period Cross-over Study of Repeated Subcutaneous Injections of Methotrexate 50mg/ml Solution Either by a Pre-filled Syringe (Reference) or by a Disposable Pre-filled Pen (Test) to Assess Patient's Preference and Self-injection Experience and to Compare the Local Tolerability in Patients With Active Rheumatoid Arthritis

Completed Phase 3 Last updated 12 July 2013

What this trial tests

Phase 3 trial testing methotrexate prefilled pen in Rheumatoid Arthritis in 120 participants. Completed in 1 June 2013.

Timeline

1 July 2012

Primary endpoint
1 April 2013

1 June 2013

Quick facts

Lead sponsor	medac GmbH
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	1 July 2012
Primary completion	1 April 2013
Estimated completion	1 June 2013
Sites	1 location across Germany

Drugs / interventions tested

methotrexate prefilled pen — full drug profile →
methotrexate prefilled syringe — full drug profile →

Conditions studied

Rheumatoid Arthritis — all drugs for Rheumatoid Arthritis →

Sponsor

medac GmbH — full company profile →

Who can join

Adults 18 to 75, 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.

number of patients preferring the MTX pre-filled pen to the pre-filled syringe
Time frame: after 6 weeks of treatment

Sponsor's own description

The primary objective of this study is to assess the number of patients preferring the methotrexate pre-filled pen to the methotrexate pre-filled syringe after 6 weeks of treatment based on a questionnaire

Publications & conference data

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

Subcutaneously administered methotrexate for rheumatoid arthritis, by prefilled syringes versus prefilled pens: patient preference and comparison of the self-injection experience.
Demary W, Schwenke H, Rockwitz K, Kästner P, et al · · 2014 · cited 40× · PMID 25125973 · DOI 10.2147/ppa.s64111
Potential Benefits of the Self-Administration of Subcutaneous Methotrexate with Autoinjector Devices for Patients: A Review.
Tornero Molina J, López Robledillo JC, Casamira Ruiz N. · · 2021 · cited 23× · PMID 33824602 · DOI 10.2147/dhps.s290771

Verify or expand the search:

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 medac GmbH trials

Trials by the same sponsor.

NCT03156790 — PK, PD, Safety and Immunogenicity of Spectrila in Adults With Acute B-cell Lymphoblastic Leukaemia · Phase 2 · terminated
NCT02333058 — Treosulfan-based Conditioning in Paediatric Patients With Haematological Malignancies · Phase 2 · completed
NCT00822393 — Clinical Phase III Trial Treosulfan-based Conditioning Versus Reduced-intensity Conditioning (RIC) · Phase 3 · completed

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 NCT01793259 (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 medac GmbH
Last refreshed: 12 July 2013

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/NCT01793259.

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