E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10039073 |
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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 |
Primary: 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) |
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E.2.2 | Secondary objectives of the trial |
Secondary: 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) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients who completed 24 weeks of participation in Study BCDO or Study BCDV, or who completed 100 weeks of participation in Study BCDM. 2. Woman must not be pregnant, breastfeeding, or become pregnant during the study. |
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E.4 | Principal exclusion criteria |
Patients will be excluded from the study if they meet any of the following criteria: 1. Presence of significant uncontrolled cerebro-cardiovascular (for example: myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic or neuropsychiatric disorders or abnormal laboratory values at baseline that in the opinion of the Investigator pose an unacceptable risk to the patient if study drug would be administered. 2. Have any other condition that renders the patient unable to understand the nature, scope, and possible consequences of the study or precludes the patient from following and completing the protocol, in the opinion of the Investigator. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Safety Endpoints: • Percentage of patients with TEAEs, AESIs, and SAEs for each LY2127399 dose • Mean change from baseline in laboratory evaluations (including chemistry, immunoglobulins, hematology, and B cell counts) for each LY2127399 dose • Percentage of patients with treatment-emergent abnormal laboratory evaluations for each LY2127399 dose • Percentage of patients with positive anti-LY2127399 antibody (Ab) titers for each LY2127399 dose Efficacy Endpoints: Efficacy will be assessed based on the following: • ACR20, ACR50, ACR70, and ACR-N indices for each LY2127399 dose • Individual components of the ACR Core Set for each LY2127399 dose • Mean change from baseline in DAS28-CRP for each LY2127399 dose • EULAR Responder Index for each LY2127399 dose |
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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 | 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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 8 |
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 |
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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
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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 | 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 |