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] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
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 aim of the current study is to explore the potential of a dose reduction of Etanercept on safety and persisting remission in RA patients. |
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E.2.2 | Secondary objectives of the trial |
Secondary, possible baseline predictors for the maintenance of remission will be explored and the percentage of patients regaining remission after a flare will be investigated. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients eligible for enrolment in the study must meet the following inclusion criteria:
- Established RA patients in remission according to DAS remission criteria for at least 6 months
- Treated with Etanercept 50mg weekly for at least one year
- DMARD treatment is allowed at a stable dose for at least 3m prior to baseline
- Stable oral corticosteroids treatment is allowed at a daily dose equal to or less than 5 mg prednisone equivalent for at least 1 month prior to randomisation
- Able and willing to give written informed consent and to participate in the study
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E.4 | Principal exclusion criteria |
Patients will be excluded from participating in the study if they meet any of the following exclusion criteria:
- Underlying cardiac, pulmonary, metabolic, renal or gastrointestinal conditions, chronic or latent infectious diseases or immune deficiency, addiction to analgesics and all diseases which in the opinion of the investigator places the patient at an unacceptable risk for continuing therapy and participation in the study
- Pregnancy, breastfeeding or no use of a reliable method of contraception
- Alcohol or drug abuse
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of patients maintaining remission 6 months after decreasing the dose of Etanercept to 50mg every 2 weeks compared to the proportion of patients maintaining remission while continuing the established dose of 50mg weekly. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Exploring baseline predictors for the maintenance of remission (including ultrasound)
- Proportion of patients maintaining remission for 1 year
- Proportion of patients maintaining remission for 6 months and 1 year according to the Boolean definition
- Proportion of patients maintaining remission for 6 months and 1 year according to the SDAI definition
- Proportion of patients regaining remission status when retreated with their original dose of Etanercept
- Evaluating the usefulness the FLARE questionnaire
- Safety: number and type of (serious) adverse events.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
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 | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
comperator is the standard dose of the same product (Enbrel 50 mg weekly versus every other week) |
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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 | 4 |
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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end of the trial: last patient last visit |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |