E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 15.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | Rheumatoid arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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)
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
at the end of the study (after 6 weeks of treatment) |
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E.5.2 | 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
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
at the end of the study (after 6 weeks of treatment) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
local safety and usability of the device |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 13 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined as the database lock |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |