Extension of the RESCUE study to follow up on long term safety and efficacy of patients with Crohn's disease that received a dose escalation after the loss of response to ustekinumab

An Open-Label Extension and long-term efficacy and safety monitoring study of patients with Crohn’s disease previously included in the loss of RESponse to Ustekinumab treated by dose Escalation study (REScUE-OLE) - RESCUE-OLE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-000345-41-BE

Enrollment

108

Registered

2021-06-15

Start date

2021-09-10

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn's disease

Interventions

Trade Name: Stelara 90 mg solution for injection n pre-filled syringue Pharmaceutical Form: Solution for injection in pre-filled syringe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Previous inclusion in the REScUE study and having reached the end of this study at week 48. 2. Adequate contraception in females of reproductive age (oral contraception, intra-uterine device, sterilisation or barrier method). 3. Have the capacity to understand and sign an informed consent form. 4. Be able to adhere to the study visit schedule and other protocol requirements. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 108 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients previously enrolled to the ustekinumab 90 mg SC Q4w-arm during REScUE who were on concomitant steroid use >20 mg prednisone equivalents (budesonide >6 mg; beclomethasone dipropionaat >5 mg) at any time point in the last 28 days before the end of REScUE at week 48. 2. Patients previously enrolled to the ustekinumab 90 mg SC Q4w-arm during REScUE that did not reach the following criteria at the end of REScUE at week 48: - Clinical remission (defined as average AP =1 and average SF =3) OR clinical response (defined as a drop of at least 50% in average AP and/or a drop of at least 50% in average SF as compared to REScUE baseline, and both average AP and SF no worse than REScUE baseline) AND - Endoscopic remission (defined as a total SES-CD 3 times the upper limit of normal range - Direct (conjugated) bilirubin level =3.0 mg/dL 5. Patients with an ongoing treatment with another concomitant biological (vedolizumab, anti-TNF), a JAK-inhibitor or any investigational product for the treatment of CD at the end of REScUE at week 48. 6. Patients who experience or have an ongoing infection event confirmed by positive stool or blood testing (including gastrointestinal pathogens, tuberculosis, HIV, hepatitis B, hepatitis C) should not initiate REScUE-OLE until (i) this event has completely resolved as shown by the termination of treatment with anti-infective medication, or (ii) this event is considered to be in stable remission under anti-infective medication in case of HIV, hepatitis B and hepatitis C. 7. Patients with an impassable stenosis even after attempt of endoscopic balloon dilatation. 8. Patients with an intra-abdominal abscess, or patients with an intra-anal abscess without adequate drainage by e.g. a seton placement.

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the long-term clinical efficacy of a ustekinumab 90mg SC Q4w regimen in patients with CD previously enrolled in the REScUE study because of secondary loss of response to a ustekinumab 90mg SC Q8w regimen.;Secondary Objective: -To assess the long-term safety of a ustekinumab 90mg SC Q4w regimen in patients with CD previously enrolled in the REScUE study because of secondary loss of response to a ustekinumab 90mg SC Q8w regimen. -To assess the long-term biochemical effect of a ustekinumab 90mg SC Q4w regimen in patients with CD previously enrolled in the REScUE study because of secondary loss of response to a ustekinumab 90mg SC Q8w regimen. -To assess the long-term endoscopic effect of a ustekinumab 90mg SC Q4w regimen in patients with CD previously enrolled in the REScUE study because of secondary loss of response to a ustekinumab 90mg SC Q8w regimen. -To assess the additional benefit of dose optimization to a ustekinumab 90mg SC Q4w regimen in patients experiencing CD worsening during treatment with a ustekinumab 90mg SC Q8w regimen. ;Primary end point(s): -Proportion of patients in both treatment arms in steroid-free clinical remission (PRO-2 remission: average AP =1 and average SF =3 without any steroid use in the previous 28 days) at both week 56 and week 112 of the study (sustained steroid-free clinical remission).;Timepoint(s) of evaluation of this end point: week 56 and week 112	—

Measure

Time frame

Main Objective: To assess the long-term clinical efficacy of a ustekinumab 90mg SC Q4w regimen in patients with CD previously enrolled in the REScUE study because of secondary loss of response to a ustekinumab 90mg SC Q8w regimen.;Secondary Objective: -To assess the long-term safety of a ustekinumab 90mg SC Q4w regimen in patients with CD previously enrolled in the REScUE study because of secondary loss of response to a ustekinumab 90mg SC Q8w regimen. -To assess the long-term biochemical effect of a ustekinumab 90mg SC Q4w regimen in patients with CD previously enrolled in the REScUE study because of secondary loss of response to a ustekinumab 90mg SC Q8w regimen. -To assess the long-term endoscopic effect of a ustekinumab 90mg SC Q4w regimen in patients with CD previously enrolled in the REScUE study because of secondary loss of response to a ustekinumab 90mg SC Q8w regimen. -To assess the additional benefit of dose optimization to a ustekinumab 90mg SC Q4w regimen in patients experiencing CD worsening during treatment with a ustekinumab 90mg SC Q8w regimen. ;Primary end point(s): -Proportion of patients in both treatment arms in steroid-free clinical remission (PRO-2 remission: average AP =1 and average SF =3 without any steroid use in the previous 28 days) at both week 56 and week 112 of the study (sustained steroid-free clinical remission).;Timepoint(s) of evaluation of this end point: week 56 and week 112

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Secondary

Measure	Time frame
Secondary end point(s): - Incidence and severity of adverse events in both treatment arms. - Time to CD worsening in both treatment arms. - Proportion of patients in both treatment arms in steroid-free clinical remission (PRO-2 remission: average AP =1 and average SF =3 without any steroid use in the previous 28 days) at week 56 of the study. - Proportion of patients in both treatment arms in steroid-free clinical remission (PRO-2 remission: average AP =1 and average SF =3 without any steroid use in the previous 28 days) at week 112 of the study. - Proportion of patients previously enrolled to the ustekinumab 90 mg SC Q8w-arm during REScUE who needed dose optimization to ustekinumab 90 mg SC Q4w at the start or during REScUE-OLE (=week 100), and that reached steroid-free clinical remission (PRO-2 remission: average AP ?1 and average SF ?3 without any steroid use in the previous 28 days) at week 112. - Proportion of patients in both treatment arms in clinical remission (PRO-2 remission: average AP =1 and average SF =3) at both week 56 and week 112 of the study (sustained clinical remission). - Proportion of patients in both treatment arms in clinical remission (PRO-2 remission: average AP =1 and average SF =3) at week 56 of the study. - Proportion of patients in both treatment arms in clinical remission (PRO-2 remission: average AP =1 and average SF =3) at week 112 of the study. - Proportion of patients previously enrolled to the ustekinumab 90 mg SC Q8w-arm during REScUE who needed dose optimization to ustekinumab 90 mg SC Q4w at the start or during REScUE-OLE (?week 100), and that reached clinical remission (PRO-2 remission: average AP =1 and average SF =3) at week 112. - Proportion of patients in both treatment arms with biomarker remission (CRP <5 mg/L and FC =250 µg/g) at week 56 of the study. - Proportion of patients in both treatment arms with biomarker remission (CRP <5 mg/L and FC =250 µg/g) at week 112 of the study. - Proportion of patients previously enrol	—

Measure

Time frame

Secondary end point(s): - Incidence and severity of adverse events in both treatment arms. - Time to CD worsening in both treatment arms. - Proportion of patients in both treatment arms in steroid-free clinical remission (PRO-2 remission: average AP =1 and average SF =3 without any steroid use in the previous 28 days) at week 56 of the study. - Proportion of patients in both treatment arms in steroid-free clinical remission (PRO-2 remission: average AP =1 and average SF =3 without any steroid use in the previous 28 days) at week 112 of the study. - Proportion of patients previously enrolled to the ustekinumab 90 mg SC Q8w-arm during REScUE who needed dose optimization to ustekinumab 90 mg SC Q4w at the start or during REScUE-OLE (=week 100), and that reached steroid-free clinical remission (PRO-2 remission: average AP ?1 and average SF ?3 without any steroid use in the previous 28 days) at week 112. - Proportion of patients in both treatment arms in clinical remission (PRO-2 remission: average AP =1 and average SF =3) at both week 56 and week 112 of the study (sustained clinical remission). - Proportion of patients in both treatment arms in clinical remission (PRO-2 remission: average AP =1 and average SF =3) at week 56 of the study. - Proportion of patients in both treatment arms in clinical remission (PRO-2 remission: average AP =1 and average SF =3) at week 112 of the study. - Proportion of patients previously enrolled to the ustekinumab 90 mg SC Q8w-arm during REScUE who needed dose optimization to ustekinumab 90 mg SC Q4w at the start or during REScUE-OLE (?week 100), and that reached clinical remission (PRO-2 remission: average AP =1 and average SF =3) at week 112. - Proportion of patients in both treatment arms with biomarker remission (CRP <5 mg/L and FC =250 µg/g) at week 56 of the study. - Proportion of patients in both treatment arms with biomarker remission (CRP <5 mg/L and FC =250 µg/g) at week 112 of the study. - Proportion of patients previously enrol

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Countries

Belgium

Contacts

Public ContactSenior Project Manager

Belgian IBD research and development (BIRD vzw)

ingrid.arijs@birdgroup.be0032499317005

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026