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 |
The primary objective of the study is to assess long-term safety of AMG 108 125 mg, 250 mg SC in subjects with RA previously enrolled in study 20050168. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study are To assess impact of concomitant immunosuppressives on long-term safety profile of AMG 108 To assess impact of comorbidity on adverse event AE profile of AMG 108 To determine whether long-term use of AMG 108 improves function in subjects with RA To assess the change in mental and physical component summaries MCS PCS and each of the 8 domain scores of SF-36 from baseline to weeks 24, 48, 96, 144 and EOS To determine effect of long- term use of AMG 108 on work productivity To evaluate long-term pharmacokinetics trough levels of AMG 108 To assess the clinical effect of AMG 108 as determined by ACR20 response at week 24, 48, 96, 144 and EOS To determine whether immunogenicity of AMG 108 affects efficacy and safety as determined by frequency, subject incidence and time-to-onset of cardiovascular safety events and changes in biomarkers related to cardiovascular disease |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
The major inclusion criteria are Subjects must have met all inclusion criteria and none of the exclusion criteria for study 20050168, were randomized and completed 24 weeks of the study. Subjects must receive their first dose of IP within 18 days from their Week 24 visit in study 20050168. Signed informed consent |
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E.4 | Principal exclusion criteria |
The major exclusion criteria are Uncontrolled or Significant concurrent medical events, in the opinion of the investigator, including - Asthma - Malignancy - Liver disease - Renal disease - Hematologic abnormality - Diabetes mellitus - Cardiovascular disease - Hypertension - Chronic inflammatory disease or connective disease other than RA or secondary Sjogren s syndrome - Infections CTC grade 3 lasting 2 consecutive weeks and/or not responding to treatment in study 20050168 Pregnant or nursing Sexually active subjects and their partners who are of childbearing potential ie, neither surgically sterile nor postmenopausal and not using adequate contraception Any physical and/or psychiatric condition that, in the opinion of the investigator, compromises the ability of the subject to give written informed consent Any condition or disorder that, in the opinion of the investigator, would interfere with compliance with study procedures Active substance abuse Requiring or having a condition that, in the opinion of the investigator, may be expected to require strong narcotic analgesics except hydrocodone, codeine, dextropropoxyphene, propoxyphene, or oxycodone or morphine derived medication for analgesic relief at screening Inability or unwillingness to self-administer or by designated person subcutaneous injections at home |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoints include the following AE Serious Adverse Event SAE Serious infectious event SIE Infectious event IE Injection site reaction ISR Change by Common Toxicity Criteria grade from baseline laboratory values Infections in subjects with neutrophil counts 1.5 x 103/ 956;L Opportunistic infections Malignant neoplasm Anti-AMG 108 antibodies by immunoassay and cell-based bioassay |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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 | 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 | No |
E.8.1.5 | Parallel group | No |
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) | Yes |
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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |