ASTIClite EBMT follow-up

Conditions

Crohn's disease Digestive System

Snowden JA, Hawkey C, Hind D, Swaby L, Mellor K, Emsley R, Mandefield L, Lee E, Badoglio M, Polge E, Labopin M, Gribben J, Pockley AG, Foulds GA, Lobo A, Travis S, Parkes M, Satsangi J, Papaioannou D, Lindsay JO, Autologous Stem Cell Transplantation In Refractory CD - Low Intensity Therapy Evaluation Study Investigators, European Society for Blood and Marrow Transplantation (EBMT) Autoimmune Diseases Working Party (ADWP).

2019-05-3118 citations

10.1186/s12876-019-0992-2

Interventions

Participants recruited to the ASTIClite RCT will be invited to take part in the EBMT follow-up study, and will sign a separate consent form. Data collected from the point of stem cell transplant (or e

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants must have consented to take part in the ASTIClite randomised controlled trial (see http://www.isrctn.com/ISRCTN17160440) 2. Participants must be willing and able to provide full informed consent, including sharing their data with the EBMT

Exclusion criteria

Exclusion criteria: Significant language barriers, which are likely to affect the participant’s understanding of the study, or ability to complete outcome questionnaires

Design outcomes

Primary

Measure	Time frame
Documentation of adverse events; Timepoint(s): At each annual follow up visit (four to seven years)	—

Secondary

Measure	Time frame
Participants are followed up annually for between 4 - 7 years, depending on when they are recruited to the ASTIClite RCT. Secondary outcome measures for the follow up study are as follows: 1. Long-term efficacy (for those patients receiving HSCT), measured using documentation of the need for further treatment at each annual follow up visit 2. Documentation of disease activity at each annual follow up visit 3. Requirement for further medical or surgical intervention at each annual follow up visit 4. Disease-specific quality of life measured using the IBD-Q questionnaire at each annual follow up visit 5. Disease-specific quality of life measured using the IBD Control questionnaire at each annual follow up visit 6. Quality of life measured using the EQ-5D-5L questionnaire at each annual follow up visit 7. Health care resource utilisation measured using the healthcare resource use questionnaire at each annual follow up visit	—

Measure

Time frame

Participants are followed up annually for between 4 - 7 years, depending on when they are recruited to the ASTIClite RCT. Secondary outcome measures for the follow up study are as follows: 1. Long-term efficacy (for those patients receiving HSCT), measured using documentation of the need for further treatment at each annual follow up visit 2. Documentation of disease activity at each annual follow up visit 3. Requirement for further medical or surgical intervention at each annual follow up visit 4. Disease-specific quality of life measured using the IBD-Q questionnaire at each annual follow up visit 5. Disease-specific quality of life measured using the IBD Control questionnaire at each annual follow up visit 6. Quality of life measured using the EQ-5D-5L questionnaire at each annual follow up visit 7. Health care resource utilisation measured using the healthcare resource use questionnaire at each annual follow up visit

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Countries

United Kingdom

Outcome results

None listed