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 |
Pain and swelling in joints |
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E.1.1.2 | Therapeutic area | Body processes [G] - Immune system processes [G12] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10039075 |
E.1.2 | Term | Rheumatoid arthritis and associated conditions |
E.1.2 | System Organ Class | 100000004870 |
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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 assess the efficacy of CNTO 6785 on the signs and symptoms in subjects with active RA compared with placebo despite concomitant methotrexate (MTX) therapy |
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E.2.2 | Secondary objectives of the trial |
1. To assess the safety and tolerability of CNTO 6785
2. To assess the impact of CNTO 6785 on physical function
3. To assess the pharmacokinetics (PK) and immunogenicity of
CNTO 6785
4. To explore PK/pharmacodynamic (PD) relationship
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Be a man or woman between 18 (at least 18 and the legal age of consent in the jurisdiction in which the study is taking place) and 80 years of age (or less if mandated by country-specific guidelines), inclusive.
• Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the American Rheumatism Association) and have had RA for at least 6 months prior to the date of signing the informed consent at screening.
• Have active RA defined study as persistent disease activity with both of the following criteria: at least 6 swollen and 6 tender joints using a 66/68 joint count at the time of screening and at baseline; and serum C-reactive protein (CRP) ≥ 0.8 mg/dL at screening or erythrocyte sedimentation rate (ESR) ≥ 28 mm in the first hour at screening or baseline.
• Have been treated with and tolerated methotrexate (MTX) treatment at dosages from 7.5 to 25 mg/week, inclusive, for a minimum of 6 months prior to screening and must have a stable MTX dose for a minimum of 6 weeks prior to the first dosing with study agent.
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E.4 | Principal exclusion criteria |
•Has inflammatory diseases other than RA, including, but not limited to adult onset Still’s disease (AOSD), Felty’s syndrome, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus, and Lyme disease that might confound the evaluation of the benefit of study agent therapy.
• Has a history of juvenile idiopathic arthritis (JIA).
•Has a diagnosis of fibromyalgia.
• Has a recent history (within 12 months prior to screening) of uncontrolled, chronic disease including, but not limited to, pulmonary, psychiatric, and metabolic disturbances, cardiovascular, endocrine, neurological, hepatic, gastrointestinal, renal, hematological, or urological diseases that the investigator believes are clinically significant.
• At screening, the results of laboratory tests must meet protocol-specified criteria.
• Has ever received any approved or investigational biologic agent for a rheumatic indication including, but not limited to, brodalumab (AMG 827), infliximab, xekizumab, secukinumab, etanercept, adalimumab, golimumab, sirukumab, certolizumab pegol, tocilizumab, abatacept, anakinra, yisaipu, and β-cell depleting therapies.
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E.5 End points |
E.5.1 | Primary end point(s) |
The proportion of participants who achieve an ACR 20 response |
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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) |
1.Change from baseline in DAS28 (CRP)
2.The proportion of participants who achieve ACR 50 response
3.The proportion of participants who achieve ACR 20/50/70 responses
4.Change from baseline of DAS28 (CRP)
5.The proportion of participants with DAS28 (CRP) response
6.The proportion of participants with DAS28 (CRP) remission
7.Change from baseline in DAS28 (ESR)
8.Change from baseline in HAQ-DI score
9.Change from baseline in SF-36
10.Change from baseline in CDAI
11.Change from baseline in SDAI
12.The proportion of participants with SDAI-based ACR/EULAR remission
13.The proportion of participants with Boolean-based ACR/EULAR remission |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. At Week 16
2. At Week 16
3. Through Week 32
4. Through Week 32
5. Through Week 32
6. At Weeks 16 and 32
7. At Weeks 16 and 32
8. Through Week 32
9. At Weeks 16 and 32
10. At Weeks 16 and 32
11. At Weeks 16 and 32
12. At Weeks 16 and 32
13. At Weeks 16 and 32
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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 | Yes |
E.6.10 | Pharmacogenetic | Yes |
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 | 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 | Yes |
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 | Yes |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 13 |
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 |
China |
Colombia |
Czech Republic |
India |
Philippines |
Poland |
Russian Federation |
Thailand |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |