Metoject (methotrexate autopen) / Medac, Eisai - LARVOL DELTA

Comparison of azathioprine to methotrexate in combination therapy with adalimumab in Crohns Disease: an open-label randomized controlled trial (clinicaltrialsregister.eu) - P2/3 | N=166 | Recruiting | Sponsor: Centre Hospitalier Universitaire Amiens Picardie | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Immunology • Inflammatory Bowel Disease

2025.36: Discontinuation of disease-modifying anti-rheumatic drugs (DMARDs) in rheumatoid arthritis patients also using TNF inhibitors (clinicaltrialsregister.eu) - P4 | N=202 | Not yet recruiting | Sponsor: Sint Maartenskliniek Stichting

Head-to-Head • New P4 trial • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Efficacy of Switching from oral to Subcutaneous Methotrexate in Alleviating Methotrexate-related Intolerance Symptoms in Japanese Patients with Rheumatoid Arthritis: The METOJECTIVE Study. (PubMed, Intern Med) - "Multivariate logistic regression analyses demonstrated that switching to subcutaneous MTX significantly improved the patient-reported nausea. Conclusions Switching from oral to subcutaneous MTX reduced intolerance symptoms compared with oral MTX in Japanese patients with RA."

Journal • Fatigue • Immunology • Inflammatory Arthritis • Rheumatoid Arthritis • Rheumatology

Preventing Structural Damage in Early Psoriatic Arthritis (clinicaltrials.gov) - P4 | N=108 | Recruiting | Sponsor: Chinese University of Hong Kong

New P4 trial • Immunology • Inflammatory Arthritis • Psoriatic Arthritis • Rheumatology • Seronegative Spondyloarthropathies

21-API-03: Methotrexate treatment in hand osteoarthritis refractory to usual treatments (clinicaltrialsregister.eu) - P1/2 | N=170 | Not yet recruiting | Sponsor: Centre Hospitalier Universitaire De Nice

New P1/2 trial • Immunology • Osteoarthritis • Pain • Rheumatology

METOJECT SUBCUTANEOUS INJECTION PEN (METHOTREXATE) PEN-TYPE AUTOINJECTOR LAUNCHED IN JAPAN (Eisai Press Release) - "Eisai Co., Ltd...and nippon medac Co., Ltd...announced today that they have launched the anti-rheumatic agent 'Metoject Subcutaneous Injection 7.5mg Pen 0.15mL, 10mg Pen 0.20mL, 12.5mg Pen 0.25mL and 15mg Pen 0.30mL' (methotrexate, 'MTX'), in Japan. The product received manufacturing and marketing approval in Japan on February 15, 2024, and was published in Japan’s National Health Insurance Drug Price List, today. Based on the license agreement signed by Eisai and medac GmbH in May 2019, nippon medac will hold the marketing authorization of Metoject, while Eisai will be responsible for product distribution of Metoject in Japan."

Launch Japan • Immunology • Rheumatoid Arthritis • Rheumatology

International survey to evaluate current options and user needs for subcutaneous injection of methotrexate to inform development of a new injection device (BSR 2024) - "To assess the needs of users and the relevance of features of a new MTX autoinjector succeeding the metoject®/metex® PEN, an international online survey was performed. A structured questionnaire was distributed to physicians, nurses and patients in Germany, France, and the United Kingdom... Autoinjectors for MTX appear to be preferred over PFS in this international survey. In addition, important features of MTX autoinjectors for patients and healthcare professionals were identified including the autoinjector mechanism, volume of injection and injection time."

Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Rheumatoid Arthritis • Rheumatology

International Survey to Evaluate Current Options for Subcutaneous Injection of Methotrexate (MTX) and a New Button-Free MTX Autoinjector. (PubMed, Patient Prefer Adherence) - "A new MTX pen with modernized button-free autoinjection technology was developed as a successor to a button-activated pen (metoject®/metex® PEN)...Arguments for the use of MTX pens as opposed to PFS predominantly refer to dosing/administration and ease of use. The new button-free MTX autoinjector combines a number of advantageous features identified by the international survey."

Journal • Dermatology • Immunology • Inflammatory Arthritis • Psoriasis • Rheumatoid Arthritis • Rheumatology

METOJECT SUBCUTANEOUS INJECTION PEN (METHOTREXATE) PEN-TYPE AUTOINJECTOR APPROVED IN JAPAN (Eisai Press Release) - "Eisai Co., Ltd...and nippon medac Co., Ltd...announced today that they have obtained manufacturing and marketing approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the additional formulation of Metoject Subcutaneous Injection for the anti-rheumatic agent....Based on the license agreement signed by Eisai and medac GmbH in May 2019, nippon medac will hold the marketing authorization of Metoject, while Eisai will be responsible for product distribution of Metoject in Japan."

Japanese regulatory • Immunology • Rheumatoid Arthritis

Methotrexate monotherapy for alopecia universalis: a successful treatment not to be overlooked (BAD 2022) - "Overall, she tolerated the treatment well, experiencing manageable fatigue; nausea, which subsided when MTX was switched from oral to subcutaneous administration (Metoject). It is safe, well tolerated; leads to cosmetically acceptable regrowth. Furthermore, it avoids the sequelae associated with corticosteroids; is a good option to consider in patients with prognostic features associated with better outcomes, such as adults; female patients."

Monotherapy • Alopecia • Atopic Dermatitis • Dermatitis • Fatigue • Immunology

Effet de la COmbinaison de Méthotrexate et d’Adalimumab sur la Réduction de l’Immunisation au cours de la Spondylarthrite ankylosante Effet de la COmbinaison de Méthotrexate et d’Adalimumab sur la Réduction de l’Immunisation au cours de la Spondylarthrite ankylosante (clinicaltrialsregister.eu) - P4; N=110; Ongoing; Sponsor: CHRU de TOURS

New P4 trial • Seronegative Spondyloarthropathies • TNFA

Anifrolumab (Saphnelo) for systemic lupus erythematosus. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

"Qu’en est-il des autres traitements? Metoject, etc." (,@Tcitron)

Low Dose Metronomic Poly-chemotherapy for Metastatic CRC (clinicaltrials.gov) - P2; N=45; Completed; Sponsor: HaEmek Medical Center, Israel; Active, not recruiting ➔ Completed; Trial completion date: Jan 2019 ➔ Dec 2019

Clinical • Trial completion • Trial completion date • KRAS