Completed PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT00114530

Scleroderma: Cyclophosphamide or Transplantation (SCOT)

A Randomized, Open-Label, Phase II Multicenter Study of High-Dose Immunosuppressive Therapy Using Total Body Irradiation, Cyclophosphamide, ATGAM, and Autologous Transplantation With Auto-CD34+HPC Versus Intravenous Pulse Cyclophosphamide for the Treatment of Severe Systemic Sclerosis (SCSSc-01)

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Conditions Autoimmune Disease Scleroderma, Systemic Sclerosis

Interventions cyclophosphamide mHSCT

Updated 13 times since 2017 Last updated: Mar 20, 2023 Started: Jun 30, 2005 Primary completion: Apr 30, 2016 Completion: Apr 30, 2016

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00114530, this PHASE2/PHASE3 trial focuses on Autoimmune Disease and Scleroderma, Systemic and remains completed. Sponsored by National Institute of Allergy and Infectious Diseases (NIAID), it has been updated 13 times since 2005, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

13 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE2/PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE2/PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2/PHASE3

Phase: PHASE2_PHASE3 → PHASE2/PHASE3
May 2023 — Jul 2024 [monthly]

Completed PHASE2_PHASE3
Dec 2021 — May 2023 [monthly]

Completed PHASE2_PHASE3

▶ Show 8 earlier versions

Sep 2021 — Dec 2021 [monthly]

Completed PHASE2_PHASE3
May 2021 — Sep 2021 [monthly]

Completed PHASE2_PHASE3
Apr 2021 — May 2021 [monthly]

Completed PHASE2_PHASE3
Jan 2021 — Apr 2021 [monthly]

Completed PHASE2_PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE2_PHASE3
Aug 2017 — Jun 2018 [monthly]

Completed PHASE2_PHASE3
Feb 2017 — Aug 2017 [monthly]

Completed PHASE2_PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2_PHASE3

First recorded

Jun 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

National Institute of Allergy and Infectious Diseases (NIAID)
Rho Federal Systems Division, Inc.

Data source: National Institute of Allergy and Infectious Diseases (NIAID)

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ann Arbor, United States , Boston, United States , Calgary, Canada , Charleston, United States , Duarte, United States , Durham, United States , Houston, United States , Lexington, United States , Los Angeles, United States , Milwaukee, United States and 5 more locations