Longitudinal Analysis And Sample Collection To Evaluate PML Risk Host Markers for PML Risk Host Markers for PML Risk (SRA-001)
|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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02440126|
Recruitment Status : Recruiting
First Posted : May 12, 2015
Last Update Posted : February 5, 2020
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Longitudinal Meta-Analysis and Further Sample Collection To Evaluate Potential Host Markers for PML Risk|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||March 2017|
|Estimated Study Completion Date :||July 2021|
Group A: Natalizumab Naïve
This group will consist of up to 10 people who are naïve to natalizumab (haven't received the drug before) and are just beginning therapy. These participants will meet with the study staff at Week 0 (Baseline) prior to their natalizumab infusion. They will then have a follow up appointment every 3 months for the first 12 months of their natalizumab infusions, for a total of 5 visits. Natalizumab concentration and other biomarkers will be measured at each visit.
Group B: Intracycle Regular Dosing
This group will consist of at least 50 people who are on a regular infusing cycle of 28-31 days. These participants will be consented at Week 0 (Baseline) and asked to come back each week during their regular cycle at Week 1, Week 2, and Week 3, for a total of 4 study visits. Natalizumab concentration and other biomarkers will be measured during their participation in the study.
Group C: Intracycle Extended Dosing
This group will consist of up to 60 people who are on an extended infusing cycle of greater than 30 days. These participants will be consented at Week 0 (Baseline) and asked to come back each week for a blood draw to measure Natalizumab concentration and other biomarkers during their extended cycle at Week 2, and Week 4, for a total of 3 study visits.
Group D: Transition Dosing
This group will consist of up to 10 people who are on a regular infusing cycle of 28-30 days who will be transitioning to an extended dosing cycle. The decision to transition will be made by their treating neurologist. These participants will be consented at Week 0 (Baseline) and will be followed for 8 cycles. Natalizumab concentration will be measured at each cycle. During certain cycles, other biomarkers will be measured.
- Pharmacokinetic (PK) Changes over Time [ Time Frame: 12 month ]Changes in natalizumab concentration (ug/ml) will be collected and compared to similar infusion cycle lengths collected previously in investigator-initiated trials at this site.
- Pharmacodynamic (PD) Changes over Time [ Time Frame: 12 month ]Changes in natalizumab saturation (%) will be collected and compared to similar infusion cycle lengths collected previously in investigator-initiated trials at this site.
Biospecimen Retention: Samples Without DNA
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): NCT02440126
|Contact: Tammy Hoyt, MS, ACRPfirstname.lastname@example.org|
|Contact: Laura Seawright, BSN, RNemail@example.com|
|United States, Utah|
|Rocky Mountain MS Research Group||Recruiting|
|Salt Lake City, Utah, United States, 84103|
|Contact: Tammy Hoyt, MS, CCRC 801-408-5700 firstname.lastname@example.org|
|Principal Investigator: John F Foley, MD|
|Principal Investigator:||John F Foley, MD||Rocky Mountain MS Research Group, LLC|