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 | 13.1 |
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 |
To evaluate the long-term safety and tolerability of ATN-103 administered SC to subjects with RA. |
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E.2.2 | Secondary objectives of the trial |
There are no pre-defined secondary objectives. Exploratory analyses are planned as described in the protocol. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Subjects must have completed study 3242K1-2000-WW or 3242K1-2001-JA and have had no events that, in the opinion of the investigator, would preclude entry or participation in this study.
2. All women of childbearing potential (WOCBP) as determined during the previous study (data must be available as source documents for this study) must have a negative urine pregnancy test result at the baseline visit and throughout the duration of the study (defined as the time of the signing of the ICF through the conclusion of subject participation).
- Women of nonchildbearing potential (WONCBP) as determined during the previous study do not require a urine pregnancy test.
3. WOCBP who have sexual intercourse with a non-surgically sterilized male partner must agree and commit to the use of the following highly effective and reliable forms of contraception: hormone contraception, double-barrier contraception (eg, condom with spermicide), or an intrauterine device for the duration of the study and for 8 weeks after the last dose of investigational product.
- To be considered surgically sterilized, a male partner must have had a vasectomy at least 24 weeks before the baseline visit.
All men (unless surgically sterile, as defined above) and WOCBP who have sexual
intercourse must agree and commit to use a highly effective and reliable form of
contraception, as stated above, for the duration of the study and for 8 weeks after the last dose of investigational product.
4. Willingness and ability to participate in all aspects of the study, including SC administration of the investigational product (by study personnel), completion of subject assessments, attending scheduled clinic visits, and compliance with all protocol requirements as evidenced by written informed consent. |
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E.4 | Principal exclusion criteria |
1. Pregnant or nursing women.
2. Any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, immunologic [eg, Felty syndrome, human immunodeficiency virus (HIV) infection], infectious, neurological, or cerebral psychiatric disease, or evidence of demyelinating disease) that, in the investigator’s judgment, will substantially increase the risk associated with the subject’s developing an adverse event (AE) or serious adverse event (SAE) during the study, or preclude the evaluation of the subject’s response.
3. Other clinically important abnormalities on the baseline physical examination or vital sign measurements (performed at week 20 in the previous study) or, any unresolved clinically significant abnormalities on laboratory tests prior to the week 20 visit.
4. Received any prohibited treatment during the previous study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
There is no pre-defined primary endpoint. The primary objective is to evaluate the long-term safety and tolerability of ATN-103 administered SC to subjects with RA. As such, a number of safety parameters will be evaluated over the period of the clinical trial. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Exploratory Analysis throughout the study |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Exploratory analysis throughout the study |
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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 | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Patient reported health outcomes |
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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 | No |
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) | 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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 19 |
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 |
Belgium |
Canada |
Germany |
Hungary |
Japan |
Russian Federation |
South Africa |
Switzerland |
United States |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 18 |
E.8.9.2 | In all countries concerned by the trial days | 0 |