Rheumatoid arthritis MedDRA version: 9.1 Level: LLT Classification code 10039073 Term: Rheumatoid arthritis
Conditions
Interventions
Product Name: Methotrexate 50mg/ml solution for injection, pre-filled syringe
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Methotrexate disodium
CAS Number: 7413345
Other descripti
Sponsors
medac Gesellschaft für klinische Spezialpräparate mbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Written informed consent • Age between 18 and 75 years • Diagnosis of rheumatoid arthritis according to the ACR criteria • Patient currently receiving oral methotrexate for at least 6 weeks and requiring an intensification of therapy due to remaining RA activity (DAS28>2.6) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Prior treatment with parenteral MTX or biologicals • Concomitant treatment with another DMARD or a biological • Renal insufficiency (creatinine in serum > 1.5ULN) • History or acute signs of hepatic insufficiency (AST or ALT > 2ULN) • Impaired haematopoiesis (platelets < 100x109/l, Leukocytes < 3.5 x 109/l), significant anaemia (Hemoglobin < 10 g/dl) • Known severe, acute or chronic infection like hepatitis B or C, tuberculosis or HIV • Ulcer of oral cavity or known ulcer of gastrointestinal tract • History or diagnosis of a dermatological disease in the area of the injection-site, which could interfere with a proper assessment • Malignant disease • Alcohol or drug addiction • Patients with a known history of any previous generalised allergic reactions or serious adverse reactions to the study medication or other components of the injection solution • Women with child bearing potential or men with a partner with child bearing potential without adequate contraception • pregnant or breast feeding women • Patients simultaneously participating or having participated in another clinical trial in the 8 weeks before study start • Patients with any form of psychiatric disorder or other conditions which in the opinion of the investigator might invalidate or complicate communication with the patient • Any subcutaneous administered drug (insulin, heparin, etc.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • The primary objective is to quantify the patient’s decision for future methotrexate treatment (50 mg/ml syringe versus 10 mg/ml syringe) following repeated subcutaneous injections of 10 mg/ml and 50 mg/ml syringes. ;Secondary Objective: • To assess the patient satisfaction with the 50 mg/ml syringe and with the 10 mg/ml syringe at the end of the study by the patient. • To evaluate any potential advantages of the fixed needle attached to the 50 mg/ml MTX prefilled syringe and of the 0.4 ml volume of the 50 mg/ml syringe in comparison to 2 ml volume of the 10 mg/ml syringe by the patient. • To assess the usability of the 10 mg/ml syringe and the usability of the 50 mg/ml syringe by the physician and patient. • To assess the local tolerability of subcutaneous injections of methotrexate 10 mg/ml and 50 mg/ml syringe, based on the local symptoms occurring at the injection site rated at every injection by patients or by physician;Primary end point(s): Patient decision for further therapy (patient questionnaire) | — |
Countries
Germany
Outcome results
None listed