E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rheumatoid arthritis
Chronic Plaque Psoriasis |
|
E.1.1.1 | Medical condition in easily understood language |
Rheumatoid arthritis
Chronic Plaque Psoriasis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10042952 |
E.1.2 | Term | Systemic rheumatoid arthritis |
E.1.2 | System Organ Class | 100000004859 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10071117 |
E.1.2 | Term | Plaque psoriasis |
E.1.2 | System Organ Class | 100000004858 |
|
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 longer-term safety and durability of response of subjects who completed 48 weeks of evaluations in the confirmatory safety and efficacy studies, CHS 0214-02 or CHS 0214-04, evaluating CHS 0214 in rheumatoid arthritis (RA) and plaque psoriasis (PsO), respectively. |
|
E.2.2 | Secondary objectives of the trial |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Have completed 48 weeks of evaluations in CHS 0214-02 and, at Week 48, had at least an ACR20, or completed 48 weeks of evaluations in CHS 0214-04 and, at Week 48, had at least a PASI-50;
2. Women who either:
a) Are of childbearing potential with a negative urine pregnancy test at
Week 0 Day 0 who agree to use 1 or more approved methods of birth
control (hormonal contraception, intrauterine device, diaphragm plus
spermicide, condom plus spermicide, or abstinence from heterosexual
intercourse—abstinence from heterosexual intercourse will be
acceptable only if it is the preferred and usual lifestyle of the subject
regardless of study participation; abstinence should be practiced for the
duration of the study Follow-up Visit 28 days after the last dose of study
drug);
b) Have been postmenopausal for at least 2 years (with amenorrhea for at least 1 year) or have had a hysterectomy, bilateral salpingo oophorectomy, or tubal ligation prior to signing the informed consent; and
3. Able and willing to give written informed consent prior to performance of any study related procedures. |
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E.4 | Principal exclusion criteria |
1. Men whose partners may become pregnant (do not agree to use contraception or who are not postmenopausal) or who may breastfeed during the study (Japan only specific exclusion). |
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E.5 End points |
E.5.1 | Primary end point(s) |
SAFETY: Safety will be assessed by:
• Assessment of treatment-emergent AEs;
• Determination of subject withdrawal information;
• Assessment of injection site reactions;
• Assessment of changes in safety laboratory parameters, including hematology, clinical chemistry, and pregnancy tests;
• Assessment of changes in vital signs, physical examination, and electrocardiogram findings;
• Monitoring for tuberculosis (TB) with regular QuantiFERON®-TB Gold test (every 12 months or more frequently for regions with high incidences of TB or to evaluate signs and symptoms that might be due to TB); and
• Assessment of immunogenicity (anti-CHS 0214 antibodies)
EFFICACY: Durability of response will be measured as follows:
• For subjects with RA, maintenance of an ACR20 response or greater
• For subjects with PsO, maintenance of PASI-50 response or greater |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
SAFTEY: At 1 month and 3 months following enrollment and every 3 months thereafter
EFFICACY: At each visit |
|
E.5.2 | Secondary end point(s) |
EFFICACY: For subjects with RA, Disease Activity Score using 28 tender
and swollen joint counts, high sensitivity C reactive protein, and
subject's global assessment (DAS28-CRP [4]) to < 3.2 (low disease
activity) assessed at all visits and < 2.6 (remission) assessed on all
visits after DAS28-CRP (4) < 2.6 is achieved
Retained Samples:
Serum samples will be collected at each visit and retained for potential analysis of serum concentration of CHS 0214, anti-drug antibodies, or other tests as necessary to evaluate AEs, loss of response, or compliance. Serum samples will not be used to assess population pharmacokinetics (PK), biomarkers, or genetics. Samples will be stored at Medpace Reference Laboratory, LLC (MRL) and may be transferred to Charles River Laboratories or other reference laboratory for analysis at the request of the Sponsor. All retained samples and remnants of samples will be destroyed 2 years after the completion of the study (data base lock). |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
EFFICACY: At all visits.
Retained Samples: Up to 2 years after completion of the study (data base lock). |
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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 | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
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) | 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 | No |
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 | 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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 15 |
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 |
Australia |
Canada |
France |
Germany |
Israel |
Italy |
Japan |
South Africa |
Spain |
United Kingdom |
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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
|
|
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 | 5 |
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 | 11 |
E.8.9.2 | In all countries concerned by the trial days | 0 |