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NCT00288990 · ClinicalTrials.gov registry record
A Serologic Study to Correlate Beta-IFN NAb Titers to Beta-IFN Induced Biomarker Response in Patients With Multiple Sclerosis
A clinical trial, sponsored by Biogen.
- Completed
- Registry status
- 300
- Enrollment target
NCT00288990: Completed study, sponsored by Biogen.
NCT00288990 is a clinical trial that has completed, run by Biogen. The registered enrollment target is 300 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00288990 has completed, sponsored by Biogen.
- COMPLETED
- Registry status
- 300 participants
- Enrollment target
Study Summary
Study Title: A Serologic Study to Correlate b-IFN NAb titers to b-IFN Induced Biomarker Response in Patients with Multiple Sclerosis Objectives: Subjects currently on any of the three b-IFN preparations (Avonex (Interferon b-1a 30 mcg IM Q 7 days), Rebif (Interferon b-1a 22 or 44mcg SC TIW), or Betaseron (Interferon b-1b 250mcg SC QOD)) will be enrolled to one of 3 groups: Group 1: Approximately 200 subjects will be enrolled who are NAb+ (titer ³ 20NU/ml) Group 2: Approximately 50 subjects will be enrolled who are BAb- (titer \<8U) and NAb- (titer \<20 NU/ml) Group 3: Approximately 50 subjects will be enrolled who are BAb+ (titer ³8U) and NAb- (titer \<20 NU/ml) The primary objective of this study is to compare baseline b-IFN induced MxA mRNA response in neutralizing antibody positive (NAb+, titers ³ 20NU/ml, Group 1) vs. antibody negative (NAb-, titers \< 20NU/ml, BAb-, titers \<8U, Group 2) patients. Secondary objectives are: 1. To compare b-IFN induced MxA mRNA response in neutralizing antibody positive (NAb+, titers ³ 20NU/ml, Group 1) vs. antibody negative (NAb-, titers \< 20NU/ml, BAb-, titers \<8U, Group 2) patients at the month 6 visit. 2. To compare b-IFN induced biomarker response (viperin, IFIT1) in neutralizing antibody positive (NAb+, titers ³ 20NU/ml, Group 1) vs. antibody negative (NAb-, titers \< 20NU/ml, BAb-, titers \<8U, Group 2) patients (data compared at baseline and month 6 visits) 3. To compare b-IFN induced biomarker response (MxA, viperin, IFIT1) in neutralizing antibody positive (NAb+, titers ³ 20NU/ml, Group 1) vs. BAb+ (titers ³8U)/NAb- (titers \<20 NU/ml, Group 3) patients at baseline and month 6 visits. 4. To correlate NAb titer levels with b-IFN induced biomarker response (data taken from baseline and month 6 visits from Group 1). 5. To compare b-IFN induced biomarker response (MxA, viperin, IFIT1) in BAb-/NAb- patients (Group 2) vs. BAb +/NAb- patients (Group 3) in order to determine if BAbs affect b-IFN induced biomarker respons
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2006-01 |
| Est. Completion | 2007-08 |
What the finished NCT00288990 record still lists
NCT00288990 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00288990 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00288990 about?
NCT00288990 is a clinical study titled "A Serologic Study to Correlate Beta-IFN NAb Titers to Beta-IFN Induced Biomarker Response in Patients With Multiple Sclerosis". Study Title: A Serologic Study to Correlate b-IFN NAb titers to b-IFN Induced Biomarker Response in Patients with Multiple Sclerosis Objectives: Subjects currently on any of the three b-IFN preparations (Avonex (Interferon b-1a 30 mcg IM Q 7 days), Rebif (Interferon b-1a 22 or 44mcg SC TIW), or Bet...
What is the current status of trial NCT00288990?
This trial is currently completed. The enrollment target is 300 participants. The study started on 2006-01. Estimated completion is 2007-08.
Who is sponsoring clinical trial NCT00288990?
This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.
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