E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Rheumatoid Arthritis Axial spondyloarthritis Psoriatic arthritis |
|
E.1.1.1 | Medical condition in easily understood language |
Inflammation of the joints and the spine |
|
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 | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003268 |
E.1.2 | Term | Arthritis rheumatoid |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10051265 |
E.1.2 | Term | Spondyloarthropathy |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10002557 |
E.1.2 | Term | Ankylosing spondylitis and other inflammatory spondylopathies |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
|
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 whether there is transfer of CIMZIA ® (CZP) across the placenta to infants from mothers by evaluating the concentration of CZP in the plasma of infants at birth |
|
E.2.2 | Secondary objectives of the trial |
To assess the concentrations of CZP and anti-CZP antibodies in the plasma of mothers at delivery
To assess the concentrations of CZP and anti-CZP antibodies in the plasma of umbilical cords at birth |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. An IRB/IEC approved written Informed Consent form for the maternal subject and written assent for her infant is signed and dated by the subject or by the legal representative. Where applicable, the written assent form for the infant is also signed and dated by the infant’s father or legal representative. 2. Subject/legal representative is considered reliable and capable of adhering to the protocol and visit schedule according to the judgment of the Investigator. 3. Subject is female ≥18 years at the time of informed consent/assent. 4. Subject is ≥30 weeks pregnant with a singleton or twins at the time of informed consent/assent. 5. Subject is being treated with CZP at a dose and administration schedule per the locally approved label. 6. Subject started, or decided to start, treatment with CZP independently from and prior to being recruited for this study and in accordance with the treating physician. 7. Subject expects to receive CZP until at least 35 days prior to expected delivery. Additional criteria to be confirmed at Visit 2 (delivery): 8. Subject delivers a live born infant at or near term (≥34 weeks gestation). 9. Subject received CZP within 35 days before delivery. 10. Subject has not received contraindicated medication |
|
E.4 | Principal exclusion criteria |
1. Subject has participated in a study of an investigational medicinal product (IMP) or medical device within the previous 30 days or 5 half-lives (whichever is longer) prior to Screening or is currently participating in another study of an IMP or medical device - unless the study is UCB UP0016 or a registry study. 2. Subject has any obstetrical or psychiatric condition, or she or her infant has any medical condition that, in the opinion of the Investigator, could jeopardize or would compromise the subject’s ability to participate in this study or the outcome of the pregnancy. 3. Subject has history of chronic alcohol abuse or drug abuse during pregnancy. 4. Subject has any pregnancy-related clinically significant abnormality noted on obstetric ultrasound, or other imaging assessment, or the subject has significant laboratory abnormalities during her pregnancy, as judged by the Investigator. 5. Subject is taking a prohibited medication or has taken a prohibited medication. 6. Subject has evidence of a condition suggesting chronic or acute uteroplacental insufficiency such as intrauterine growth restriction, severe maternal hypertensive disorders of pregnancy, or abruption. 7. Subject has a documented history of primary or secondary antiphospholipid syndrome or hypercoagulable state. 8. Subject has received treatment with any biological therapeutic agent, including anti-TNFs other than CZP, during pregnancy. 9. Subject has previously participated in this study. 10. Subject has a positive or indeterminate QuantiFERON®-TB GOLD In Tube test at Screening. In case of indeterminate result, a retest is allowed if time permits; 2 results of indeterminate require exclusion of the subject (see also exclusion criterion 11 – definition of latent tuberculosis [LTB]). Tuberculosis (TB) test results that have been obtained within the previous 60 days prior to Screening are acceptable (QuantiFERON®-TB GOLD or purified protein derivative [PPD] test). 11. Subject has known TB infection, at high risk of acquiring TB infection or latent TB infection as specified in the protocol. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The plasma concentration of CZP in the infant at birth |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Delivery/birth Samples for assessing PK parameters will be obtained at delivery/birth: - A blood sample within 24 hours after birth from the infant
|
|
E.5.2 | Secondary end point(s) |
1. The plasma concentration of CZP in the mother at delivery 2. The ratio between plasma concentration of CZP between the infant and mother at birth 3. The plasma concentration of CZP in the umbilical cord at birth 4. The plasma concentration of anti-CZP antibodies in the mother at delivery 5. The plasma concentration of anti-CZP antibodies in the umbilical cord at birth
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Delivery/birth Samples for assessing PK parameters will be obtained at delivery/birth: - A blood sample within 24 hours after birth from the infant - A blood sample within 24 hours before/after delivery from the mother - A blood sample directly after delivery (within ≤1 hour) from the umbilical cord
|
|
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 | No |
E.6.5 | Efficacy | No |
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 | 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) | Yes |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | Yes |
E.7.1.3.1 | Other trial type description |
Clinical Pharmacology Postauthorisation safety Study (PASS) |
|
E.7.2 | Therapeutic exploratory (Phase II) | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
postmarketing, prospective study |
|
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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 |
France |
Germany |
Netherlands |
Switzerland |
United States |
|
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
|
|
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 | 10 |
E.8.9.1 | In the Member State concerned days | 16 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 12 |