Trial Outcomes & Findings for Rebif® Pregnancy Registry (NCT NCT00338741)
NCT ID: NCT00338741
Last Updated: 2013-08-05
Results Overview
Number of participants having spontaneous abortion
Recruitment status
COMPLETED
Target enrollment
36 participants
Primary outcome timeframe
Up to 9 months
Results posted on
2013-08-05
Participant Flow
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.
Participant milestones
| Measure |
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
|
Non-Rebif Exposed Pregnancies
Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
2
|
|
Overall Study
COMPLETED
|
32
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
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
|
Non-Rebif Exposed Pregnancies
Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Rebif® Pregnancy Registry
Baseline characteristics by cohort
| Measure |
Rebif Exposed Pregnancies
n=34 Participants
Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta \[IFN-beta\]-1a) during pregnancy or within one week of conception
|
Non-Rebif Exposed Pregnancies
n=2 Participants
Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
34 participants
n=5 Participants
|
2 participants
n=7 Participants
|
36 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 9 monthsPopulation: Population includes all subjects for whom data is available
Number of participants having spontaneous abortion
Outcome measures
| Measure |
Rebif Exposed Pregnancies
n=32 Participants
Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta \[IFN-beta\]-1a) during pregnancy or within one week of conception
|
Non-Rebif Exposed Pregnancies
n=2 Participants
Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
|
|---|---|---|
|
Spontaneous Abortion
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 10 monthsFetal death/stillbirth
Outcome measures
| Measure |
Rebif Exposed Pregnancies
n=32 Participants
Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta \[IFN-beta\]-1a) during pregnancy or within one week of conception
|
Non-Rebif Exposed Pregnancies
n=2 Participants
Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
|
|---|---|---|
|
Fetal Death/Stillbirth
|
1 Participants
|
0 Participants
|
Adverse Events
Rebif Exposed Pregnancies
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Rebif Exposed Pregnancies
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rebif Exposed Pregnancies
n=32 participants at risk
Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta \[IFN-beta\]-1a) during pregnancy or within one week of conception
|
Non-Rebif Exposed Pregnancies
n=2 participants at risk
Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Premature labor/premature delivery
|
6.2%
2/32 • Number of events 2 • From study entry until pregnancy outcome. For the purposes of this Registry, the protocol captured as adverse events only unexpected pregnancy events.
These events included spontaneous abortion, stillbirth, elective abortion, anomalies diagnosed at birth, termination or the 28-day follow-up evaluation, labor/delivery complications, pre-eclampsia/eclampsia, premature labor/delivery, and "other" to be specified by the Investigator.
|
0.00%
0/2 • From study entry until pregnancy outcome. For the purposes of this Registry, the protocol captured as adverse events only unexpected pregnancy events.
These events included spontaneous abortion, stillbirth, elective abortion, anomalies diagnosed at birth, termination or the 28-day follow-up evaluation, labor/delivery complications, pre-eclampsia/eclampsia, premature labor/delivery, and "other" to be specified by the Investigator.
|
|
Pregnancy, puerperium and perinatal conditions
Spontaneous abortion
|
6.2%
2/32 • Number of events 2 • From study entry until pregnancy outcome. For the purposes of this Registry, the protocol captured as adverse events only unexpected pregnancy events.
These events included spontaneous abortion, stillbirth, elective abortion, anomalies diagnosed at birth, termination or the 28-day follow-up evaluation, labor/delivery complications, pre-eclampsia/eclampsia, premature labor/delivery, and "other" to be specified by the Investigator.
|
0.00%
0/2 • From study entry until pregnancy outcome. For the purposes of this Registry, the protocol captured as adverse events only unexpected pregnancy events.
These events included spontaneous abortion, stillbirth, elective abortion, anomalies diagnosed at birth, termination or the 28-day follow-up evaluation, labor/delivery complications, pre-eclampsia/eclampsia, premature labor/delivery, and "other" to be specified by the Investigator.
|
|
Pregnancy, puerperium and perinatal conditions
Failed induction
|
6.2%
2/32 • Number of events 2 • From study entry until pregnancy outcome. For the purposes of this Registry, the protocol captured as adverse events only unexpected pregnancy events.
These events included spontaneous abortion, stillbirth, elective abortion, anomalies diagnosed at birth, termination or the 28-day follow-up evaluation, labor/delivery complications, pre-eclampsia/eclampsia, premature labor/delivery, and "other" to be specified by the Investigator.
|
0.00%
0/2 • From study entry until pregnancy outcome. For the purposes of this Registry, the protocol captured as adverse events only unexpected pregnancy events.
These events included spontaneous abortion, stillbirth, elective abortion, anomalies diagnosed at birth, termination or the 28-day follow-up evaluation, labor/delivery complications, pre-eclampsia/eclampsia, premature labor/delivery, and "other" to be specified by the Investigator.
|
|
Pregnancy, puerperium and perinatal conditions
Failed labour progression
|
3.1%
1/32 • Number of events 1 • From study entry until pregnancy outcome. For the purposes of this Registry, the protocol captured as adverse events only unexpected pregnancy events.
These events included spontaneous abortion, stillbirth, elective abortion, anomalies diagnosed at birth, termination or the 28-day follow-up evaluation, labor/delivery complications, pre-eclampsia/eclampsia, premature labor/delivery, and "other" to be specified by the Investigator.
|
0.00%
0/2 • From study entry until pregnancy outcome. For the purposes of this Registry, the protocol captured as adverse events only unexpected pregnancy events.
These events included spontaneous abortion, stillbirth, elective abortion, anomalies diagnosed at birth, termination or the 28-day follow-up evaluation, labor/delivery complications, pre-eclampsia/eclampsia, premature labor/delivery, and "other" to be specified by the Investigator.
|
|
Pregnancy, puerperium and perinatal conditions
Uterine fibroids
|
3.1%
1/32 • Number of events 1 • From study entry until pregnancy outcome. For the purposes of this Registry, the protocol captured as adverse events only unexpected pregnancy events.
These events included spontaneous abortion, stillbirth, elective abortion, anomalies diagnosed at birth, termination or the 28-day follow-up evaluation, labor/delivery complications, pre-eclampsia/eclampsia, premature labor/delivery, and "other" to be specified by the Investigator.
|
0.00%
0/2 • From study entry until pregnancy outcome. For the purposes of this Registry, the protocol captured as adverse events only unexpected pregnancy events.
These events included spontaneous abortion, stillbirth, elective abortion, anomalies diagnosed at birth, termination or the 28-day follow-up evaluation, labor/delivery complications, pre-eclampsia/eclampsia, premature labor/delivery, and "other" to be specified by the Investigator.
|
|
Pregnancy, puerperium and perinatal conditions
Gestational diabetes
|
3.1%
1/32 • Number of events 1 • From study entry until pregnancy outcome. For the purposes of this Registry, the protocol captured as adverse events only unexpected pregnancy events.
These events included spontaneous abortion, stillbirth, elective abortion, anomalies diagnosed at birth, termination or the 28-day follow-up evaluation, labor/delivery complications, pre-eclampsia/eclampsia, premature labor/delivery, and "other" to be specified by the Investigator.
|
0.00%
0/2 • From study entry until pregnancy outcome. For the purposes of this Registry, the protocol captured as adverse events only unexpected pregnancy events.
These events included spontaneous abortion, stillbirth, elective abortion, anomalies diagnosed at birth, termination or the 28-day follow-up evaluation, labor/delivery complications, pre-eclampsia/eclampsia, premature labor/delivery, and "other" to be specified by the Investigator.
|
|
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
|
3.1%
1/32 • Number of events 1 • From study entry until pregnancy outcome. For the purposes of this Registry, the protocol captured as adverse events only unexpected pregnancy events.
These events included spontaneous abortion, stillbirth, elective abortion, anomalies diagnosed at birth, termination or the 28-day follow-up evaluation, labor/delivery complications, pre-eclampsia/eclampsia, premature labor/delivery, and "other" to be specified by the Investigator.
|
0.00%
0/2 • From study entry until pregnancy outcome. For the purposes of this Registry, the protocol captured as adverse events only unexpected pregnancy events.
These events included spontaneous abortion, stillbirth, elective abortion, anomalies diagnosed at birth, termination or the 28-day follow-up evaluation, labor/delivery complications, pre-eclampsia/eclampsia, premature labor/delivery, and "other" to be specified by the Investigator.
|
Other adverse events
Adverse event data not reported
Additional Information
Liz Gedney/Clinical Trial Leader
EMD Serono
Phone: +781 681-2179
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER