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 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 |
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 |
• 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
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E.4 | Principal exclusion criteria |
• Current symptoms of a serious disorder or illness |
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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 |
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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) |
•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
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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 | 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.8.2.4 | 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 | 11 |
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 | No |
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 |
Argentina |
Australia |
Brazil |
Bulgaria |
Colombia |
Croatia |
France |
Germany |
Greece |
Hungary |
India |
Italy |
Japan |
Korea, Republic of |
Lithuania |
Malaysia |
Mexico |
New Zealand |
Peru |
Poland |
Romania |
Russian Federation |
Slovakia |
South Africa |
Spain |
Sri Lanka |
Taiwan |
Ukraine |
United States |
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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 | 6 |
E.8.9.1 | In the Member State concerned months | 10 |
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 |