A study comparing two different therapeutic approaches in the treatment of moderate to severe ulcerative colitis.

SPRINT: AN OPEN-LABEL, MULTICENTER STUDY TO EVALUATE STEP-UP VS TOP-DOWN TREATMENT ALGORITHMS IN MODERATE TO SEVERE ULCERATIVE COLITIS - SPRINT

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-003420-16-ES

Enrollment

350

Registered

2021-06-23

Start date

2021-08-11

Completion date

Unknown

Last updated

2021-08-17

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

Conditions

Moderate to severe ulcerative colitis MedDRA version: 20.1 Level: LLT Classification code 10045365 Term: Ulcerative colitis System Organ Class: 100000004856

Interventions

Trade Name: Amgevita Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ADALIMUMAB CAS Number: 331731-18-1 Current Sponsor code: EMEA/H/C/004212 Other descriptive n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Adult patients (age = 18 years and =65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: - Have received any kind of treatment approved for UC (thiopurine, biologics, tofacitinib) apart from 5-ASA compounds, sulphasalazine or EcN during their UC history or currently receiving local or systemic steroids (past steroids treatments are accepted) - Have concomitant history of segmental colitis associated to diverticula - Have active infections during the screening phase (patients can be rescreened after the infection is resolved - Have a diagnosis of Crohn’s disease - Have any contra-indication to study drugs or procedures - Are pregnant or in active breastfeeding at the time of inclusion. - Have planned intestinal surgery at time of randomization - Any contra-indication to anti-TNF therapy

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess the efficacy of a top-down approach in achieving histological improvement at week 52, without colectomy and without UC-related hospitalization versus a standard step-up approach.;Secondary Objective: Secondary objectives will be: - to compare the efficacy of the top-down approach to induce histological remission and histological healing in the short-term (week 16) vs. the standard step-up approach - to compare the efficacy of the top-down approach to induce clinical remission (combined clinical and endoscopic improvement=sub-score of 0 or 1) in the short- and long-term (week 16 and week 52) vs. the standard step-up approach - to compare the efficacy of the top-down approach to induce short- and long-term mucosal healing (endoscopic and histologic improvement) vs. the standard step-up approach - to compare the safety of the top-down approach through week 52 vs. the standard step-up approach - to compare the quality of life of patients treated with the top-down approach through week 52 vs. the standard step-up approach - To compare the need for colectomies and UC-related hospitalizations in patients treated with the top-down approach vs. the step-up approach.;Primary end point(s): Histological improvement (defined as a Nancy index = 1) at week 52, without colectomy and without UC-related hospitalization.;Timepoint(s) of evaluation of this end point: Week 52	—

Measure

Time frame

Main Objective: The primary objective is to assess the efficacy of a top-down approach in achieving histological improvement at week 52, without colectomy and without UC-related hospitalization versus a standard step-up approach.;Secondary Objective: Secondary objectives will be: - to compare the efficacy of the top-down approach to induce histological remission and histological healing in the short-term (week 16) vs. the standard step-up approach - to compare the efficacy of the top-down approach to induce clinical remission (combined clinical and endoscopic improvement=sub-score of 0 or 1) in the short- and long-term (week 16 and week 52) vs. the standard step-up approach - to compare the efficacy of the top-down approach to induce short- and long-term mucosal healing (endoscopic and histologic improvement) vs. the standard step-up approach - to compare the safety of the top-down approach through week 52 vs. the standard step-up approach - to compare the quality of life of patients treated with the top-down approach through week 52 vs. the standard step-up approach - To compare the need for colectomies and UC-related hospitalizations in patients treated with the top-down approach vs. the step-up approach.;Primary end point(s): Histological improvement (defined as a Nancy index = 1) at week 52, without colectomy and without UC-related hospitalization.;Timepoint(s) of evaluation of this end point: Week 52

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Secondary

Measure	Time frame
Secondary end point(s): - Histological remission (Nancy Index =0) at week 16 - Histological remission (Nancy Index =0) at week 52 - Histological healing (defined as a Nancy score = 1) at week 16 - Clinical remission (PRO2 remission + endoscopic remission) at week 52 - Clinical remission (PRO2+endoscopic remission) at week 16 - Symptomatic remission (PRO2 remission) at week 16 - Symptomatic remission (PRO2 remission) at week 52 - Endoscopic improvement at week 16 Endoscopic improvement at week 52 - Endoscopic remission at week 16 - Endoscopic remission at week 52 - Mucosal healing (endoscopic and histologic improvement) at week 16 - Mucosal healing (endoscopic and histologic improvement) at week 52 - Changes in fecal calprotectin levels from baseline - Need for corticosteroids at weeks 16 and 52 - To evaluate and compare the safety of the two strategies in terms of adverse events, serious adverse events, and adverse events leading to discontinuation - quality of life (measured by the S-IBDQ and SF-36) at weeks 16 and 52 - Rates of colectomies at weeks 16, 52, and 104 (or end of study) - UC-related hospitalizations at weeks 16, 52, and 104 (or end of study);Timepoint(s) of evaluation of this end point: Weekd 16 and/or week 52, depending on the endpoints	—

Measure

Time frame

Secondary end point(s): - Histological remission (Nancy Index =0) at week 16 - Histological remission (Nancy Index =0) at week 52 - Histological healing (defined as a Nancy score = 1) at week 16 - Clinical remission (PRO2 remission + endoscopic remission) at week 52 - Clinical remission (PRO2+endoscopic remission) at week 16 - Symptomatic remission (PRO2 remission) at week 16 - Symptomatic remission (PRO2 remission) at week 52 - Endoscopic improvement at week 16 Endoscopic improvement at week 52 - Endoscopic remission at week 16 - Endoscopic remission at week 52 - Mucosal healing (endoscopic and histologic improvement) at week 16 - Mucosal healing (endoscopic and histologic improvement) at week 52 - Changes in fecal calprotectin levels from baseline - Need for corticosteroids at weeks 16 and 52 - To evaluate and compare the safety of the two strategies in terms of adverse events, serious adverse events, and adverse events leading to discontinuation - quality of life (measured by the S-IBDQ and SF-36) at weeks 16 and 52 - Rates of colectomies at weeks 16, 52, and 104 (or end of study) - UC-related hospitalizations at weeks 16, 52, and 104 (or end of study);Timepoint(s) of evaluation of this end point: Weekd 16 and/or week 52, depending on the endpoints

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Countries

Austria, Belgium, France, Germany, Italy, Portugal, Spain, Sweden, Switzerland, United Kingdom

Contacts

Public Contactcontact@bcom.eu

B-COM

contact@bcom.eu+33680476085

Outcome results

None listed

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