Trial Outcomes & Findings for Rheumatoid Arthritis:Tolerance Induction by Mixed Chimerism (NCT NCT00282412)

Results Overview

The number of participants who survived treatment

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

4 participants

Primary outcome timeframe

up to 5 years

Results posted on

2018-07-30

Participant milestones
Measure	Hematopoietic Stem Cell Transplantation Allogeneic Hematopoietic Stem Cell Transplantation will be performed on eligible patients diagnosed with RA Hematopoietic Stem Cell Transplantation: Allogeneic Hematopoietic Stem Cell Transplantation
Overall Study STARTED	4
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	2

Reasons for withdrawal
Measure	Hematopoietic Stem Cell Transplantation Allogeneic Hematopoietic Stem Cell Transplantation will be performed on eligible patients diagnosed with RA Hematopoietic Stem Cell Transplantation: Allogeneic Hematopoietic Stem Cell Transplantation
Overall Study Death	2

Rheumatoid Arthritis:Tolerance Induction by Mixed Chimerism

Baseline characteristics by cohort
Measure	Hematopoietic Stem Cell Transplantation n=4 Participants Allogeneic Hematopoietic Stem Cell Transplantation will be performed on eligible patients diagnosed with RA Hematopoietic Stem Cell Transplantation: Allogeneic Hematopoietic Stem Cell Transplantation
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	40.00 years STANDARD_DEVIATION 12.91 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants

Timeframe: up to 5 years

Population: The number of participants who survived treatment

The number of participants who survived treatment

Outcome measures
Measure	Hematopoietic Stem Cell Transplantation n=4 Participants Allogeneic Hematopoietic Stem Cell Transplantation will be performed on eligible patients diagnosed with RA Hematopoietic Stem Cell Transplantation: Allogeneic Hematopoietic Stem Cell Transplantation
Survival	2 Participants

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events
Measure	Hematopoietic Stem Cell Transplantation n=4 participants at risk Allogeneic Hematopoietic Stem Cell Transplantation will be performed on eligible patients diagnosed with RA Hematopoietic Stem Cell Transplantation: Allogeneic Hematopoietic Stem Cell Transplantation
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute leukemia	25.0% 1/4 • Number of events 1 • Up to 5 years All adverse events will be collected at 6 months, 1 year and then yearly up to five years
Blood and lymphatic system disorders Pulmonary embolus	25.0% 1/4 • Number of events 1 • Up to 5 years All adverse events will be collected at 6 months, 1 year and then yearly up to five years

Other adverse events
Measure	Hematopoietic Stem Cell Transplantation n=4 participants at risk Allogeneic Hematopoietic Stem Cell Transplantation will be performed on eligible patients diagnosed with RA Hematopoietic Stem Cell Transplantation: Allogeneic Hematopoietic Stem Cell Transplantation
Infections and infestations Step bovis infection	25.0% 1/4 • Number of events 1 • Up to 5 years All adverse events will be collected at 6 months, 1 year and then yearly up to five years
Infections and infestations Urinary tract infection (UTI)	25.0% 1/4 • Number of events 1 • Up to 5 years All adverse events will be collected at 6 months, 1 year and then yearly up to five years
Infections and infestations Sinus infection	25.0% 1/4 • Number of events 2 • Up to 5 years All adverse events will be collected at 6 months, 1 year and then yearly up to five years

Northwestern University

Phone: 312-695-4960