Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| C0168T71 | Other Identifier | Janssen Biotech, Inc. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is collection and analysis of information pertaining to pregnancy outcomes in women exposed to infliximab during pregnancy, relative to the background risk in similar but non-biologic exposed patients; and information pertaining to health status, during the first year following delivery, of infants born to women following prenatal exposure to infliximab and their unexposed counterparts.
This registry will analyze birth outcomes data from Medical Birth Registers on approximately 370 women who have become pregnant and have been exposed to infliximab with the diseases of interest: Inflammatory Bowel Disease (Crohn's Disease [CD] and Ulcerative Colitis [UC]), Rheumatoid Arthritis [RA], Psoriatic Arthritis [PsA], Ankylosing Spondylitis [AS], and Psoriasis (Pso) as well as all women with the same diseases who have not been exposed to infliximab. Demographics and information related to the diseases of interest, past medical history, infliximab exposure during pregnancy (and up to 3 months prior to conception), use of other medications, and pregnancy outcomes information and infant birth information will be collected from the Swedish national health registries (a. Swedish Medical Birth Register [SMBR] b. Swedish Prescribed Drug Register c. Swedish Patient Register [PAR]), Danish national health registries (a. Danish Medical Birth Register [DMBR] b. Danish Register of Medicinal Product Statistics c. Danish National Patient Registry), and Finnish national health registries (a. Finnish Medical Birth Register [FMBR] b. Finnish Register on Prescribed Medicine c. Finnish National Care Register for Health Care Institutions [HILMO] d. Finnish Register on Congenital Malformations) during the study period. The health status of infants born to these women will be followed for 1 year after birth. During the 1-year follow-up period, information related to hospitalizations and antibiotic use will be obtained. No study medications will be administered in this registry. Treatments are as prescribed by the physician on the basis of usual clinical practice.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1a: Remicade Cohort | Female patients who were exposed to Remicade at any time during pregnancy (and up to 3 months prior to LMP, if this information is available). |
| |
| Group 1b: Remicade Cohort | Infants born to Group 1a patients. |
| |
| Group 2a: Other Anti-TNF agents Cohort | Female patients who were exposed to anti-TNFs other than Remicade at any time during pregnancy (and up to 3 months prior to LMP, if this information is available). |
| |
| Group 2b: Other Anti-TNF agents Cohort | Infants born to Group 2a patients. |
| |
| Group 3a: Non-biologic Systemic Therapy Control Cohort | Female patients who were exposed to systemic therapy other than biologic agents at any time during pregnancy (and up to 3 months prior to LMP, if this information is available). |
| |
| Group 3b: Non-biologic Systemic Therapy Control Cohort |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention | Other | This is an observational study. Patients receiving infliximab or anti-TNF as per the prescribing information will be observed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of normal live birth observed in pregnant women exposed and not exposed to infliximab | 5 years | |
| Number of abnormal live birth observed in pregnant women exposed and not exposed to infliximab | Abnormal live birth will be considered if the birth outcome is preterm birth, small for gestational age/intrauterine growth retardation, malformations, or perinatal morbidity. | 5 years |
| Number of fetal death observed in pregnant women exposed and not exposed to infliximab | 5 years | |
| Number of normal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab | 5 years | |
| Number of abnormal live birth observed in pregnant women with disease entity of interest exposed and not exposed to infliximab | Abnormal live birth will be considered if the birth outcome is preterm birth, small for gestational age/intrauterine growth retardation, malformations, or perinatal morbidity. | 5 years |
| Number of fetal death observed in pregnant women with disease entity of interest exposed and not exposed to infliximab | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic use and hospital care during the first year after birth for infliximab exposed and non-exposed infants | 5 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Female patients of child bearing age with one of the diseases of interest and infants delivered by such patients.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Biotech, Inc. Clinical Trial | Janssen Biotech, Inc. | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Infants born to Group 3a patients. |
|
| Group 4a: Population Control Cohort | Female patients with no record of the diseases of interest and no exposure to biologic or non-biologic systemic therapy at any time during pregnancy (and up to 3 months prior to LMP, if the information is available). |
|
| Group 4b: Population Control Cohort | Infants born to Group 4a patients. |
|
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D001172 | Arthritis, Rheumatoid |
| D015535 | Arthritis, Psoriatic |
| D013167 | Spondylitis, Ankylosing |
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D000089183 | Axial Spondyloarthritis |
| D000844 | Ankylosis |
Not provided
Not provided