Natalizumab (Tysabri) Re-Initiation of Dosing (STRATA)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00297232 |
|
Recruitment Status :
Terminated
First Posted : February 28, 2006
Results First Posted : May 29, 2015
Last Update Posted : July 15, 2016
|
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Relapsing-Remitting Multiple Sclerosis | Drug: Natalizumab | Phase 3 |
Study 101-MS-322 (NCT00306592) was conducted to evaluate the safety of natalizumab monotherapy following re-exposure to natalizumab in former clinical trial participants in Studies C-1801 (NCT00027300), C-1802 (NCT00030966), and C-1803 (NCT00097760) and included subjects in North America. In parallel with the conduct of that study, this study (101-MS-321 [NCT00297232]) was initiated for participants in Europe and the rest of the world. In addition, after 48 weeks, participants from 101-MS-322 (NCT00306592) could enter study 101-MS-321 (NCT 00297232), which was considered the Long-Term Treatment Period of 101-MS-322 (NCT00306592).
The primary purpose and primary outcome for both studies are identical; therefore, the combined long-term data from both studies are presented. (Combined Week 48 data from both studies are presented in the 101-MS-322 [NCT00306592] record.)
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1094 participants |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | An Open-Label, Multicenter, Extension Study to Evaluate the Safety and Tolerability of Natalizumab Following Re-Initiation of Dosing in Multiple Sclerosis Subjects Who Have Completed Study C-1801, C-1802, C-1803, or C-1808 and a Dosing Suspension Safety Evaluation |
| Study Start Date : | March 2006 |
| Actual Primary Completion Date : | April 2014 |
| Actual Study Completion Date : | April 2014 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Natalizumab
300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks
|
Drug: Natalizumab
Other Name: Tysabri (BG00002) |
- Time to 24-week Confirmed Expanded Disability Status Scale (EDSS) Progression [ Time Frame: up to 480 weeks ]Time to 24-week confirmed EDSS progression in participants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and < 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 24 weeks.
- Time to 48-week Confirmed EDSS Progression [ Time Frame: up to 480 weeks ]Time to 48-week confirmed EDSS progression in particpants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 48-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and < 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 48 weeks.
- Time to 24-week Confirmed EDSS Improvement Where Baseline ≥ 2.0 [ Time Frame: Up to 480 weeks ]Time to 24-week confirmed EDSS improvement in subjects with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS improvement is defined as ≥ 1.0 point decrease from baseline sustained for 24 weeks.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Key Inclusion Criteria
- MS subjects who completed Study C-1801 (NCT00027300), C-1802 (NCT00030966), or C-1803 (NCT00097760) and a Dosing Suspension Safety Evaluation (neurological examination or a magnetic resonance imaging scan) or participated in the IMA 04001 (STARS) Study
- Subjects who are considered by the Investigator to be free of signs and symptoms suggestive of progressive multifocal leukoencephalopathy and willing to discontinue and remain free from concomitant immunosuppressive or immunomodulatory treatment (including IFN-beta and glatiramer acetate) while being treated with natalizumab during the study.
- In addition, subjects who completed 48 weeks of treatment in Study 101-MS-322 (NCT00306592) in Canada will be allowed to enter this study at the start of the long-term treatment period (Week 52 - 480).
Key Exclusion Criteria
- Considered by the Investigator to be immunocompromised
- History of persistent anti-natalizumab antibodies, based upon testing from prior natalizumab studies
- History of any major disease or malignancy
- Discontinued natalizumab in a previous study due to allergic reaction
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00297232
Show 112 Study Locations
| Study Director: | Medical Director | Biogen |
Additional Information:
Publications of Results:
| Responsible Party: | Biogen |
| ClinicalTrials.gov Identifier: | NCT00297232 History of Changes |
| Other Study ID Numbers: |
101-MS-321 |
| First Posted: | February 28, 2006 Key Record Dates |
| Results First Posted: | May 29, 2015 |
| Last Update Posted: | July 15, 2016 |
| Last Verified: | May 2015 |
Keywords provided by Biogen:
|
Multiple Sclerosis MS |
Additional relevant MeSH terms:
|
Sclerosis Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Natalizumab Immunologic Factors Physiological Effects of Drugs |