Who is sponsoring NCT01871961?

NCT01871961 is sponsored by medac GmbH.

What drugs are being tested in NCT01871961?

Interventions in NCT01871961: Methotrexate (Metoject® prefilled pen).

What condition does NCT01871961 study?

NCT01871961 studies Rheumatoid Arthritis (RA).

Is NCT01871961 still recruiting?

NCT01871961 is currently completed. Last updated 13 March 2015.

Last reviewed 2015-03-13 · How we verify

NCT01871961

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

Evaluation of Rheumatoid Arthritis Patient Performance Using the Metoject® Prefilled Pen (Methotrexate 50 mg/mL, Prefilled Pen) for Subcutaneous Injection and Subsequent Pharmacokinetic Assessment of Drug Delivery

Completed Phase 1 Last updated 13 March 2015

What this trial tests

Phase 1 trial testing Methotrexate (Metoject® prefilled pen) in Rheumatoid Arthritis (RA) in 105 participants. Completed in 1 May 2013.

Timeline

1 October 2012

Primary endpoint
1 February 2013

1 May 2013

Quick facts

Lead sponsor	medac GmbH
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	105
Start date	1 October 2012
Primary completion	1 February 2013
Estimated completion	1 May 2013
Sites	1 location across United States

Drugs / interventions tested

Methotrexate (Metoject® prefilled pen) — full drug profile →

Conditions studied

Rheumatoid Arthritis (RA) — all drugs for Rheumatoid Arthritis (RA) →

Sponsor

medac GmbH — full company profile →

Who can join

16 and older, any sex, with Rheumatoid Arthritis (RA). 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.

To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).
Time frame: 1 year
Questionnaires to assess the comprehension of the label (instruction for use of the prefilled pen) and device robustness evaluation after usage of the prefilled pen

Sponsor's own description

To evaluate the human factors/usability of Rheumatoid Arthritis (RA) patients with the Metoject® prefilled pen (including a label comprehension assessment and a device robustness evaluation).

Publications & conference data

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

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
Assessing usability, label comprehension, pen robustness and pharmacokinetics of a self-administered prefilled autoinjector pen of methotrexate in patients with rheumatoid arthritis.
Pachon JA, Kivitz AJ, Heuer KU, Pichlmeier U. · · 2014 · cited 13× · PMID 26770759 · DOI 10.1177/2050312114564241

Verify or expand the search:

Other trials of Methotrexate (Metoject® prefilled pen)

Trials testing the same drug.

NCT07486843 — Preventing Structural Damage in Early Psoriatic Arthritis · Phase 4 · recruiting

Other recruiting trials for Rheumatoid Arthritis (RA)

Currently open trials in the same condition.

NCT07087912 — Safety and Immunogenicity of the Live Attenuated Tetravalent Butantan-Dengue Vaccine in Autoimmune Rheumatic Diseases · Phase 4 · recruiting
NCT07438652 — Effect of Mediterranean vs Paleolithic Diet on RA Activity, Sarcopenia and QOL: 12-Week RCT · NA · recruiting
NCT07264101 — Validity And Reliability Of The Four Square Step Test In Individuals With Rheumatoid Arthritis · recruiting
NCT07221890 — A Trial of Academic Detailing to Promote Prescribing of Biosimilars · NA · active not recruiting
NCT07100873 — A Phase 1 Study of ADI-001 in Rheumatoid Arthritis · 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 NCT01871961 (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: 13 March 2015

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/NCT01871961.

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