Multiple Sclerosis
Conditions
Brief summary
The objective for establishing the Rebif® Pregnancy Registry is to collect prospective outcomes data on women in the United States and Canada who have been exposed to Rebif® during their pregnancies. The primary end point will be the rate of spontaneous abortions in exposed pregnancies. This rate will be compared with the rate of spontaneous abortions in patients with Multiple Sclerosis (MS) whose pregnancies were not exposed to any interferon-beta in a manner consistent with the FDA August 2002 Guidance for Industry: Establishing Pregnancy Exposure Registries
Detailed description
This study is a post-approval commitment to follow Rebif®-exposed pregnancies and compare them to non-Rebif® exposed pregnancies to evaluate rate of spontaneous abortion, fetal abnormality or pregnancy related health outcomes.
Interventions
None listed
Sponsors
Pfizer
EMD Serono
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Rebif®-Exposed Group For prospective follow-up, women in the United States and Canada shall be eligible for enrollment in the Rebif® Pregnancy Registry as subjects if: * They are pregnant. * They received Rebif® for treatment of Multiple Sclerosis (MS) within one week before or at any time after conception. * The outcome of pregnancy has not been previously evaluated by any diagnostic method such as ultrasound. However, since ultrasound techniques are often used at early stages to confirm pregnancy, patients who have been evaluated by ultrasound for the purpose of confirming the pregnancy shall be eligible for enrollment in the Registry. The use of ultrasound and any inferences that could be made about the outcome of the patient's pregnancy will be reported on the case report form. Following enrollment in the Registry, diagnostic tests may be performed at any time during the pregnancy. * They have not used Copaxone® for treatment of MS within the previous three months and have not been exposed to Novantrone®, Imuran®, Cytoxan®, Tysabri® or methotrexate at any time. Patients who have been exposed to an investigational product or procedure within the previous year may be enrolled at the discretion of the Medical Director. The enrolling physician should contact Serono's authorized agent, a company called Registrat, at 866-997-3243 to request a review of each patient's situation. Interferon-beta -Not Exposed Comparison Group Women with MS who live in the United States or Canada will be eligible for the comparison group if: * They are pregnant. * The outcome of pregnancy has not been previously evaluated by any diagnostic method such as ultrasound. However, since ultrasound techniques are often used at early stages to confirm pregnancy, patients who have been evaluated by ultrasound for the purpose of confirming the pregnancy shall be eligible for enrollment in the Registry. The use of ultrasound and any inferences that could be made about the outcome of the patient's pregnancy will be reported on the case report form. Following enrollment in the Registry, diagnostic tests may be performed at any time during the pregnancy. * They have not received any interferon-beta within 90 days of conception. * They have not used Copaxone® for treatment of MS within the previous three months and have not been exposed to Novantrone®, Imuran®, Cytoxan®, Tysabri® or methotrexate at any time. Patients who have been exposed to an investigational product or procedure within the previous year may be enrolled at the discretion of the Medical Director. The enrolling physician should contact Serono's authorized agent, a company called Registrat, at 866-997-3243 to request a review of each patient's situation.
Exclusion criteria
* Not Applicable
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Spontaneous Abortion | Up to 9 months | Number of participants having spontaneous abortion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Death/Stillbirth | Up to 10 months | Fetal death/stillbirth |
Countries
United States
Participant flow
Recruitment details
35 physicians in clinical practice in the United States participated in the Registry. Physicians were practicing obstetricians and neurologists who evaluated the subjects as part of their clinical practices.Between 30 Sep 2002 to 15 Feb 2008, 207 subjects were contacted about the Registry. Enrollment was terminated on 07 Dec 2007.
Participants by arm
| Arm | Count |
|---|---|
| Rebif Exposed Pregnancies Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta \[IFN-beta\]-1a) during pregnancy or within one week of conception | 34 |
| Non-Rebif Exposed Pregnancies Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception | 2 |
| Total | 36 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 2 | 0 |
Baseline characteristics
| Characteristic | Rebif Exposed Pregnancies | Non-Rebif Exposed Pregnancies | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 2 Participants | 35 Participants |
| Region of Enrollment United States | 34 participants | 2 participants | 36 participants |
| Sex: Female, Male Female | 34 Participants | 2 Participants | 36 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 2 |
| serious Total, serious adverse events | 10 / 32 | 0 / 2 |
Outcome results
Primary
Spontaneous Abortion
Number of participants having spontaneous abortion
Time frame: Up to 9 months
Population: Population includes all subjects for whom data is available
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rebif Exposed Pregnancies | Spontaneous Abortion | 2 Participants |
| Non-Rebif Exposed Pregnancies | Spontaneous Abortion | 0 Participants |
Secondary
Fetal Death/Stillbirth
Fetal death/stillbirth
Time frame: Up to 10 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rebif Exposed Pregnancies | Fetal Death/Stillbirth | 1 Participants |
| Non-Rebif Exposed Pregnancies | Fetal Death/Stillbirth | 0 Participants |