Rheumatoid Arthritis MedDRA version: 15.1 Level: PT Classification code 10039073 Term: Rheumatoid arthritis System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: metex® 50 mg/ml Injektionslösung, Fertigspritze
Product Name: metex® 50 mg/ml Injektionslösung, Fertigspritze
Product Code: 70930.00.00
Pharmaceutical Form: Solution for injection in pre-f
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 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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: To assess the number of patients preferring the MTX pre-filled pen or the pre-filled syringe at the end of the study based on a 6-items questionnaire To compare the self-injection experience of the patients after each treatment period. To compare the local tolerability of subcutaneous injections injected with pre-filled syringes and disposable pre-filled pens at the injection site. To assess the incidence of adverse events during study To assess the number of study nurses and investigators preferring the MTX pre-filled pen at the end of study (last patient last visit). To document dysfunctions of the pre-filled pen ;Primary end point(s): • To assess the number of aptients preferring the MTX pre-filled pen to the pre-filled syringe after 6 weeks of treatment;Timepoint(s) of evaluation of this end point: at the end of the study (after 6 weeks of treatment);Main Objective: The primary objective is to assess the number of patients preferring the MTX pre-filled pen to the pre-filled syringe after 6 weeks of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • To assess the number of patients preferring the MTX pre-filled pen at the end of study based on a 6-item questionnaire related to the overall ease of use, acceptability and satisfaction • To compare the self-injection experience of the patients after each treatment period using the Self-Injection Assessment Questionnaire (SIAQ) • To compare the local tolerability of subcutaneous injections with pre-filled syringes and disposable pre-filled pens at the injection sites rated by the investigator 30 minutes after the 1st and 4th injection • To compare the local tolerability of subcutaneous injections with pre-filled syringes and disposable pre-filled pens at the injection sites rated by the patient 30 minutes (except 1st and 4th injection), 2 hours, 24 hours and 48 hours after injection. • To assess the incidence of adverse events during study • To assess the number of study nurses and investigators preferring the MTX pre-filled pen at the end of study (last patient last visit) • To document dysfunction of the pre-filled pen with respect to any information identifying and describing incidents in which the pre-filled pen was misused, broken, incapable of being activated, or did not deliver the appropriate dose ;Timepoint(s) of evaluation of this end point: at the end of the study (after 6 weeks of treatment) | — |
Countries
Germany
Contacts
Public ContactCécile Guimbal-Schmolck, PhD
medac Gesellschaft für klinische Spezialpräparate mbH
Outcome results
None listed