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This study has been withdrawn prior to enrollment.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

October 7, 2008
July 29, 2009
November 2008
August 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00771043 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
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
Optical Coherence Tomography as a Measure of Neuroprotection in Patients With Relapsing-Remitting Multiple Sclerosis Receiving Natalizumab or Interferon Beta-1a

Phase IV, proof-of-concept, randomized, open-label, multi-center, two-arm, 9-month study to evaluate the neuroprotective effects of Natalizumab (TYSABRI®) or Interferon beta-1a (AVONEX®) 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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Relapsing-Remitting Multiple Sclerosis
Drug: TYSABRI and AVONEX
TYSABRI and AVONEX treatment per package insert.
  • No Intervention: TYSABRI
    Intervention: Drug: TYSABRI and AVONEX
  • No Intervention: AVONEX
    Intervention: Drug: TYSABRI and AVONEX
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
50
June 2010
August 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00771043
US 010-07-NAT
No
Richard Kim, MD, Biogen Idec
Biogen Idec
Not Provided
Not Provided
Biogen Idec
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP