Regulate-RA Trial
Trial Therapy
Rheumatoid Arthritis (RA)
About Clinical Research
Trial Clinic Locations
For Participating Sites
Archived Materials
Please click below to view and download study related materials.
HCP Materials
VAS Assessment - Patient & Physician Combined V1
Participant Emergency Contact Card V1
Participant Thank You Card V1
Subject Eligibility Forms (combined PDF) - V09JAN2024
Subject Eligibility Forms (combined PDF) - V26OCT2023
Subject Eligibility Forms (combined PDF) - V10AUG2023
Pre-Screening Slot Request Form - V22SEP2023
Pre-Screening Checklist V1
Pre-Screening Checklist V2
Schedule of Assessments (Baseline – Safety Follow-Up) V5
Schedule of Assessments (Baseline – Safety Follow-Up) V6
Schedule of Assessments (Screening – Pretreatment) V5
Schedule of Assessments (Screening – Pretreatment) V6
Lab & Specimen Collection Supporting Materials
Synovial Biopsy Manual V1
Synovial Biopsy Manual V2
Lab Manual V1
Lab Manual V2
Lab Manual V3
Lab Manual V4
Quick Reference Guide (QRC) V1
Quick Reference Guide (QRC) V2
Quick Reference Guide (QRC) V3
Quick Reference Guide (QRC) V4
Quick Reference Guide (QRC) V5
Quick Reference Guide (QRC) V6
Quick Reference Guide (QRC) V7
Apheresis Collection Protocol V1
Apheresis Collection Protocol V2
ISF Binder
Table of Contents V1
Study Team List V06NOV2023
Study Team List V04OCT2024
ClinTrak ARM Site Instructions V15AUG2023
Study Supplies Request Template V1
Protocol V1
Protocol V2
Protocol V5
Protocol V6
Protocol Clarification Letter 1
Protocol Clarification Letter 1.1
Protocol Clarification Letter 2
Protocol Clarification Letter 3
Investigator's Brochure V1
Investigator's Brochure V2
Investigator's Brochure V3
SMC Charter V1
SMC Charter V2
SMC Charter V3
Lab Manual V1
Lab Manual V2
Lab Manual V3
Lab Manual V4
Quick Reference Guide (QRC) V1
Quick Reference Guide (QRC) V2
Quick Reference Guide (QRC) V3
Quick Reference Guide (QRC) V4
Quick Reference Guide (QRC) V5
Quick Reference Guide (QRC) V6
Quick Reference Guide (QRC) V7
Lab Re-Supply Form V1
Lab Re-Supply Form V2
Lab Re-Supply Form V3
Lab Re-Supply Form V4
eCRF Completion Guidelines V1
eCRF Completion Guidelines V2
eCRF Completion Guidelines V3
eCRF Completion Guidelines V4
Study Operations Manual V1
Study Operations Manual V2
Study Operations Manual V3
Study Operations Manual V4
Apheresis Collection Protocol V1
Apheresis Collection Protocol V2
Synovial Biopsy Manual V1
Synovial Biopsy Manual V2
Cell Therapy Binder
Study Team List 06Nov2023
Study Team List 04Oct2024
ClinTrak Access Request Management Site Instructions V15Aug2023
Study Supplies Request Template V1
Protocol V1
Protocol V2
Protocol V5
Protocol V6
Protocol Clarification Letter 1
Protocol Clarification Letter 1.1
Protocol Clarification Letter 2
Protocol Clarification Letter 3
Investigator's Brochure V1
Investigator's Brochure V3
Apheresis Collection Protocol V1
Apheresis Collection Protocol V2
Lab Resupply Form V1
Lab Resupply Form V2
Lab Resupply Form V3
Lab Resupply Form V4
Patient Materials & Diaries
Enhanced Brochure V1
Enhanced Brochure V2
Participant Handbook V1
Participant Handbook V2
Participant Journey V1
Participant Journey V2
Participant Diary Week 1 V1
Participant Diary Week 2 V1
Participant Diary Week 3 V1
Participant Diary Week 4 V1
Participant Diary Week 5-6 V1
Participant Diary Week 7-8 V1
Participant Diary Week 9-10 V1
Participant Diary Week 11-12 V1
Participant Diary Week 13-18 V1
Participant Diary Week 19-24 V1
Participant Diary Week 25-36 V1
Participant Diary Week 37-48 V1
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