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NCT02052167
Human Factors Study for the Evaluation of the Methotrexate Prefilled Pen (50 mg/mL) for Subcutaneous Injection in Pediatric and Adolescent Patients With Juvenile Idiopathic Arthritis
EARLY_PHASE1 trial testing methotrexate prefilled pen in Juvenile Idiopathic Arthritis in 30 participants. Completed in 1 August 2014.
1 August 2014
Quick facts
| Lead sponsor | medac GmbH |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 30 |
| Start date | 1 April 2014 |
| Primary completion | 1 August 2014 |
| Estimated completion | 1 August 2014 |
| Sites | 1 location across United States |
Drugs / interventions tested
- methotrexate prefilled pen — full drug profile →
Conditions studied
- Juvenile Idiopathic Arthritis — all drugs for Juvenile Idiopathic Arthritis →
Sponsor
medac GmbH — full company profile →
Who can join
Adults 2 to 20, any sex, with Juvenile Idiopathic 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.
-
Evaluation of test case scenarios with observation and performance measures
Time frame: 8 days
Test case scenarios were designed to determine if the potential risks associated with the use of the prefilled pen were mitigated by information contained in the patient leaflet and the training provided to each patient or caregiver. The test case scenarios with observation and performance measures will be evaluated.
Sponsor's own description
This study is planned to evaluate the human factor (HF)/usability of pediatric or adolescent JIA patients and the caregivers of Juvenile Idiopathic Arthritis (JIA) patients with the Methotrexate Prefilled Pen (including a label comprehension assessment and a device robustness evaluation).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02052167
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Juvenile Idiopathic Arthritis
Currently open trials in the same condition.
- NCT07243782 — Regulatory Post-Marketing Surveillance in Hidradenitis Suppurativa, Pediatric Plaque Psoriasis and JIA Treated With Cose · recruiting
- NCT05879419 — Recombinant Herpes Zoster Vaccine in Patients With Autoimmune Rheumatic Diseases · Phase 4 · active not recruiting
- NCT06007456 — Clinical, Laboratory and Ultrasound Stratification of Patients With Juvenile Idiopathic Arthritis · recruiting
- NCT03913962 — Health and Exercise Response in Children With Chronic and Auto-immune Pathologies · NA · recruiting
- NCT06560606 — UCAN CAN-DU: Canada-Netherlands Personalized Medicine Network in Childhood Arthritis and Rheumatic Disease · 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)
- Trial protocol + status: ClinicalTrials.gov NCT02052167 (US National Library of Medicine, public domain)
- 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: 26 March 2018
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/NCT02052167.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing