Comparison of the patient's experience with the methotrexate pre-filled syringe and with the methrotexate pre-filled pen and preference of the patient for subcutaneous methotrexate injection.

• Conditions: Rheumatoid Arthritis; MedDRA version: 15.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2012-000222-21-DE
• Lead Sponsor: medac Gesellschaft für klinische Spezialpräparate mbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-16
• Last Update Posted: 13 May 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Written informed consent
- Age between 18 and 75 years
- Diagnosis of definite rheumatoid arthritis according to the ACR Criteria (1987) or ACR/EULAR (2010)
- Patient requiring initiation or intensification of MTX 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 120
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

- Prior or other current subcutaneous treatment with self-injection
- Prior or concomitant treatment with biologics
- Renal insufficiency (creatinine > 1.5 ULN)
- History or acute signs of hepatic insufficiency (ALT or AST > 2 x ULN, bilirubin > 5 mg/dl)
- Impaired haematopoiesis (platelets < 100 x 109/L, leukocytes < 3,5 x 109/L ), significant anaemia (haemoglobin < 10 g/dl)
- Known severe, acute or chronic infection like hepatitis B or C, tuberculosis or HIV
- Active ulcer of oral cavity or 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 (except treated basal carcinoma and complete remission > 5 year for all other malignancies)
- Known 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 who do not use a highly effective method of contraception (pearl index < 1%) such as combined oral contraceptive, hormone IUCD, vaginal hormone ring, transdermal contraceptive patch, contraceptive implant or depot contraceptive injection in combination with a second method of contraception like a condom or a cervical cap / diaphragm with spermicide during the study and at least 6 months thereafter.
- Men who have a partner with child-bearing potential and do not use a condom or a cervical cap / diaphragm with spermicide during the study and at least 6 months thereafter.
- 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
- Insufficient knowledge in German to understand perfectly the questionnaires
- Concurrent vaccination with live vaccines

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified