E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | Rheumatoid arthritis |
|
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 of this study is to evaluate the safety and tolerability of 120 mg LY2127399 every 4 weeks (Q4W) (LY A) or 90 mg LY2127399 every 2 weeks (Q2W) (LY B) in patients with RA who completed Study BCDM, Study BCDO, or Study BCDV. Safety and tolerability assessments will include: • Treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs), and serious adverse events (SAEs) • Laboratory evaluations (including chemistry, immunoglobulins, hematology, and B cell counts) • Immunogenicity (anti-LY2127399 antibodies) |
|
E.2.2 | Secondary objectives of the trial |
The secondary objective of the study is to examine in patients with RA the effect over time of long term administration of LYA and LY B on the following outcomes: • American College of Rheumatology (ACR) 20% response (ACR20), ACR 50% response (ACR50), ACR 70% response (ACR70), and ACR percent improvement (ACR-N) indices • Individual components of the ACR Core Set • Disease Activity Score using a 28 joint count (DAS28) and C-reactive protein level (CRP) (DAS28-CRP) • European League Against Rheumatism Responder Index based on the 28 joint count (EULAR 28) • Medical Outcomes Study 36-Item Short Form Health Survey (SF 36) |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Completion of 24 weeks of participation in Study H9B-MC-BCDO or Study H9B-MC-BCDV, or have completed 100 weeks of participation in Study H9B-MC-BCDM • Woman must not be pregnant, breastfeeding, or become pregnant during the study
|
|
E.4 | Principal exclusion criteria |
• Current symptoms of a serious disorder or illness |
|
E.5 End points |
E.5.1 | Primary end point(s) |
• Percentage of patients developing anti-LY2127399 antibodies • Change from baseline in absolute B cell counts • Change from baseline in serum immunoglobulin (Ig) levels • Percentage of patients with American College of Rheumatology 20% (ACR20), 50% (ACR50) and 70% (ACR70) response • Change from baseline in Disease Activity Score-C-Reactive Protein (DAS28-CRP) • Percentage of patients with DAS28-Based European League Against Rheumatism (EULAR-28) response • Change from baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) domain scores and summary scores • Change from baseline in Tender Joint Count (68 joint count) • Change from baseline in Swollen Joint Count (66 joint count) • Change from baseline in Patient's Assessment of Pain (VAS) • Change from baseline in Patient's Global Assessment of Disease Activity (VAS) • Change from baseline in Physician's Global Assessment of Disease Activity (VAS) • Change from baseline in Health Assessment Questionnaire-Disability Index HAQ-DI • Change from baseline in CRP • Mean percent improvement in ACR-N |
|
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 | 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 | Yes |
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 | No |
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 | 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 | No |
E.8.2.3 | Other | No |
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 | 17 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 100 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
|
E.8.7 | Trial has a data monitoring committee | Yes |
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 7 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |