E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Mild to moderate rheumatoid arthritis |
|
E.1.1.1 | Medical condition in easily understood language |
|
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 | 16.1 |
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 |
|
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 |
To assess the effect on disease activity of treatment with TCZ+MTX combination therapy versus TCZ Monotherapy by change in DAS28 score from week 12 (time of randomization) to week 24. |
|
E.2.2 | Secondary objectives of the trial |
- To assess other efficacy parameters such as DAS28 remission CDAI remission, SDAI remission, RADAI-5 remission - To assess quality of life parameters.
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Diagnosis of RA of ≥ 1 years duration (or radiologic evidence of RA if diagnosis of RA < 1 year) and mild to moderate disease activity at screening (defined as DAS 28 ≤ 4,5 and > 2,6) - Patients currently receiving MTX for at least 12 weeks and who have received MTX at a stable dose of at least 15mg/week for at least 6 weeks prior to treatment (day 1). Patients with a history of parenteral (subcutaneous or intramuscular) MTX prior to baseline are eligible. However, prior to treatment (day 1) these patients must have been on a stable dose of oral MTX of at least 15 mg/week for at least 6 weeks - Age ≥ 18 years. - Body weight < 150kg |
|
E.4 | Principal exclusion criteria |
- Rheumatic autoimmune disease other than RA - Functional class IV as defined by the ACR Classification of Functional Status in RA - Treatment with a biologic agent at any time prior to baseline. - Treatment with traditional non-biologic DMARDs other than MTX within 1 month (for leflunomide 3 months) prior to baseline - History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies - Evidence of serious uncontrolled concomitant cardiovascular, nervous system, pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine (including uncontrolled diabetes mellitus) or GI disease - Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections |
|
E.5 End points |
E.5.1 | Primary end point(s) |
- To assess the effect on disease activity of treatment with TCZ+MTX combination therapy versus TCZ Monotherapy with regard to the following primary endpoint in patients with mild to moderate rheumatoid arthritis (RA): - Change in DAS28 score from week 12 (time of randomization) to week 24 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
- Proportion of patients who achieve DAS28 remission at 24 weeks (DAS28 < 2,6) - Proportion of patients who achieve CDAI remission (CDAI < 2,8) at 24 weeks - Proportion of patients who achieve SDAI remission (SDAI < 3,3) at 24 weeks - Proportion of patients who achieve RADAI remission (RADAI-5 score ranging from 0 to 1.4) - Improvement in physical & mental health (HAQ-DI, SF-12, VAS Fatigue) - Incidence of adverse events and serious adverse events during study period - Patients’ satisfaction with treatments (TSQM)
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
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) | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
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
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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
|
The end of study is defined as the last visit of the last participating patient in this study (LPLV; week 24) or when the sponsor decides to discontinue the study. |
|
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 | 8 |
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 | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |