A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a (PRTOECT)

This study has been withdrawn prior to enrollment.

(Sponsor decision to withdraw study at this time.)

Sponsor:

Information provided by:

Biogen Idec

ClinicalTrials.gov Identifier:

NCT00771043

First received: October 7, 2008

Last updated: July 29, 2009

Last verified: July 2009

History of Changes

Tracking Information
First Received Date ^ICMJE	October 7, 2008
Last Updated Date	July 29, 2009
Start Date ^ICMJE	November 2008
Estimated Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 9, 2008)	Changes in average RNFL thickness as measured by OCT of affected eyes across treatment groups. [ Time Frame: Between week 4 and weeks 36 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00771043 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 9, 2008)	Changes in average RNFL thickness of affected eyes (corrected by fellow eyes) across treatment groups. [ Time Frame: Between week 4 and weeks 36 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Proof-of-Concept Study to Correlate Retinal Nerve Fiber Layer Changes in Patients With Multiple Sclerosis Treated With Natalizumab or Interferon Beta 1-a
Official Title ^ICMJE	Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a
Brief Summary	Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to evaluate the neuroprotective effects of Natalizumab (TYSABRIÂ®) or Interferon beta-1a (AVONEXÂ®) treatments initiated at the time of acute optic neuritis (AON) as measured by RNFL thickness from Optical Coherence Tomography in patients with Relapsing Remitting Multiple Sclerosis (RRMS).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Relapsing-Remitting Multiple Sclerosis
Intervention ^ICMJE	Drug: TYSABRI and AVONEX TYSABRI and AVONEX treatment per package insert.
Study Arm (s)	No Intervention: TYSABRI Intervention: Drug: TYSABRI and AVONEX No Intervention: AVONEX Intervention: Drug: TYSABRI and AVONEX
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Withdrawn
Estimated Enrollment ^ICMJE	50
Estimated Completion Date	June 2010
Estimated Primary Completion Date	August 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Diagnosis of RRMS. Patients with unilateral AON consistent with Multiple Sclerosis (MS). Treatment with intravenous methylprednisolone (IVMP) at 1gm daily for three days after the onset of AON, without a taper, and completed within 14 days of the AON symptom onset. Age 18-55 years. Expanded Disability Status Scale (EDSS) 0 to 5.0. Understand and sign informed consent. Exclusion Criteria: History or presence of progressive multifocal leukoencephalopathy (PML). Diagnosis of Primary Progressive Multiple Sclerosis (PPMS) or Secondary Progressive Multiple Sclerosis (SPMS). Immune-compromised in the judgment of the Investigator. History of or presence of clinically significant medical illness or laboratory abnormality that, in the opinion of the investigator or Sponsor, would preclude participation in the study. Concomitant ophthalmologic disorders (e.g. diabetes, macular degeneration, etc). Previous history of severe disc edema, hemorrhage, or > 1 confirmed optic neuritis (ON) with the most recent ON symptom onset being less than 12 months ago. Previous treatment with > 1 Disease Modifying Therapy (DMT). Previous treatment with investigational products for MS, immunosuppressant or cytotoxic therapy. Previous treatment with TYSABRI® Women who are not postmenopausal, surgically sterile, or willing to practice contraception. Women pregnant, breast feeding, or planning to become pregnant. Involved with other study protocol simultaneously without prior approval. Determined not suitable for study participation by Investigator and/or Sponsor.
Gender	Both
Ages	18 Years to 55 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT00771043
Other Study ID Numbers ^ICMJE	US 010-07-NAT
Has Data Monitoring Committee	No
Responsible Party	Richard Kim, MD, Biogen Idec
Study Sponsor ^ICMJE	Biogen Idec
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Biogen Idec
Verification Date	July 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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