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 | LLT |
E.1.2 | Classification code | 10039073 |
E.1.2 | Term | Rheumatoid arthritis |
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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 |
To evaluate the safety and tolerability of LY2127399 60 mg administered as SC injections once every 4 weeks (Q4W) for 48 weeks in patients with RA who have completed at least 24 weeks of participation in Study BCDG or Study BCDH and received at least 6 weeks or 12 weeks of study drug, respectively. |
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E.2.2 | Secondary objectives of the trial |
• To evaluate the long-term efficacy of LY2127399 compared to baseline. • To evaluate the impact of long term administration of LY2127399 on patient-reported outcomes. • To evaluate the long term impact of LY2127399 administration on selected peripheral blood biomarkers, including anti-Cyclic Citrullinated Peptide antibody (anti-CCP), rheumatoid factor (RF), immunoglobulins, B cells, and selected peripheral B cell subsets. • To explore the potential associations between selected biomarkers (baseline and response to treatment) and selected disease activity measures • To explore the potential development of anti-LY2127399 antibodies following long-term dosing. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients are eligible to be included in the study only if they meet all of the following criteria: [1] Have participated for at least 24 weeks in either Study BCDG (EudraCT no.: 2008-001105-42 )or Study BCDH (EudraCT no.: 2008-004894-16) and received at least 6 weeks or 12 weeks of study drug, respectively. Visit 1 of Study BCDI should be completed on the same calendar day as the Week 24 visit of the previous study. [2] Women must not be pregnant, breastfeeding, or at risk to become pregnant during study participation and must have a negative pregnancy test. Women of childbearing potential must use a medically permitted form of contraception during the whole study. Methods of contraception considered acceptable are oral contraceptives, contraceptive patch, intrauterine device (IUD), vaginal ring, diaphragm, condom with contraceptive gel, tubal ligation/sterilization, and vasectomy. [3] Have given written informed consent approved by Lilly or its designee and the Investigational Review Board/Ethical Review Board (IRB/ERB) governing the site. |
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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] Have had, during Study BCDG or Study BCDH, any safety event, (including having a recent, ongoing, or serious infection, a serious drug reaction, or any AE that caused discontinuation from treatment), that in the opinion of the investigator poses an unacceptable risk to participation in this study. [2] Have received, during Study BCDG or Study BCDH, any drug not allowed by the study protocol including unapproved drugs, biologic DMARDs, or live vaccines. [3] Investigator site personnel directly affiliated with this study and/or their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted. [4] Employees of Lilly or its designee. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The final time point of these analyses is 52 weeks, with patients not observed at 52 weeks imputed by last observation carried forward (LOCF). All analyses (ACR20, CR50,ACR70, ACR-N, DAS28, and EULAR28) will be performed using a 95% confidence interval. The goal of this analysis is to examine the profile of responses over the course of the study period. This will include analyses at each time point and 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 | 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 | Yes |
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) | 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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 57 |
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 | 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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |