Ulcerative ColitisRETUCASNCT05431283
Real-world Effectiveness of Tofacitinib on Ulcerative Colitis Associated Spondyloarthropathy
An observational study of Ulcerative Colitis and Spondyloarthropathy, run by Italian Group for the study of Inflammatory Bowel Disease (IG-IBD) at 1 site in Italy.
Trial summary
Tofacitinib (TOFA) is a JAK inhibitor already used in rheumatology for the treatment of moderate-to-severe active rheumatoid arthritis and psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease- modifying antirheumatic drugs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis, Spondyloarthropathy
- What is being tested?
- Tofacitinib
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 25 Apr 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients aged 18 years or older admitted at each IG-IBD center that agrees to participate could be be screened for inclusion
Who may be able to join
- An established diagnosis of UC and an established diagnosis of axial and/or peripheral SpA according to the Assessment of Spondyloarthritis international Society (ASAS) criteria
- Indication for treatment with TOFA as a therapy for UC according to the clinical practice and summary of product characteristics
- Active SpA at baseline assessed with an Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP ≥ 1.3 in case of axial SpA, and with a disease activity score (DAS)28-CRP ≥ 2.6 in case of peripheral SpA.
- Capability to express a written informed consent for the study
Who cannot join
- Rheumatologic diseases other than UC-associated SpA (for example, previous diagnosis of rheumatoid arthritis or psoriatic arthritis)
- Inactive SpA at baseline
- Inability to understand or sign the informed consent
- Contraindications to treatment with TOFA (pregnancy, risk factors for venous thromboembolism, active infections, hepatic failure)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IBD Unit, Department of Internal Medicine, "Villa Sofia-Cervello" Hospital
Palermo
Macaluso Fabio, MD, fsmacaluso@gmail.com
Macaluso Fabio, MD
About this study
Official title: Efficacia Nel Mondo Reale di Tofacitinib Sulla Spondiloartropatia Associata Alla Colite Ulcerosa
Tofacitinib (TOFA) is a JAK inhibitor already used in rheumatology for the treatment of moderate-to-severe active rheumatoid arthritis and psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease- modifying antirheumatic drugs. Furthermore, TOFA has been recently approved for the treatment of adult patients with moderate-to-severe active Ulcerative Colitis (UC) who had no response, lose response, or were intolerant to either conventional therapy or a biologic agent. The approval was based on the efficacy demonstrated by TOFA in three phase 3 randomized controlled trials named OCTAVE: two identically designed, 8-week, placebo- controlled, induction studies of oral TOFA 10 mg twice daily followed by the OCTAVE Sustain 52-week maintenance study. About sacroiliitis, 2 out of 8 patients treated with TOFA improved after 8 weeks, compared with 0 out of 3 patients in the placebo group. Obviously, these data should be interpreted with extreme caution since patient numbers were very low, and it should be again emphasized that these trials were not designed to explore the efficacy of TOFA onextraintestinal manifestations.
On these premises, we designed a prospective, multicenter, observational, 52-week study with the aim of assess the effectiveness of TOFA on UC-associated spondyloarthropathy.
Read the detailed description
Participants will receive TOFA at study entry (week 0) as treatment for UC according to standard clinical practice and recommended dosage of the drug, and will be followed up to 52 weeks. At baseline, all enrolled patients will undergo a detailed assessment including gender, age, duration of disease, smoking status, extension of disease (according to Montreal classification), clinical activity (assessed with the partial Mayo Score), C-Reactive Protein (CRP) values, faecal calprotectin, previous and concomitant therapies, data on SpA (axial vs. peripheral SpA, and assessment of ASDAS-CRP and/or DAS28-CRP scores). The joint response (JR), steroid free joint response (SFJR), clinical intestinal response (CIR), steroid free clinical intestinal remission (SFCIR), CRP and calprotectin values will be assessed at 8, 24 and 52 weeks (see further for the definitions of the outcomes). The burden of UC and therapy with TOFA on work productivity and health- related quality of life will be evaluated through the administration of the Work Productivity and Activity Impairment (WPAI) Questionnaire and the Short Inflammatory Bowel Disease Questionnaire Score (Short IBDQ), respectively, at baseline and at 24 and 52 weeks. The patients will be assessed with direct visits and biochemical evaluations, including monitoring of serum lipid levels, according to the routine clinical practice established for subjects treated with TOFA. The support by a rheumatologist is suggested in the clinical evaluation of patients All data will be collected anonymously in a specifically arranged eCRF form inside the IG-IBD registry.
- Conditions
- Ulcerative Colitis, Spondyloarthropathy
- Being tested
- Tofacitinib
- Medical subject headings
- Colitis, Ulcerative, Spondylarthropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TofacitinibDrug
This study aims to assess the effectiveness of TOFA
What is being measured
The primary outcome is the main question the study is designed to answer.
joint response and steroid free joint response
evaluate the rate of patients achieving joint response and steroid free joint response on Ulcerative Colitis-associated spondyloarthropathy at week 8, 24, and 52
Measured: week 8
joint response and steroid free joint response
evaluate the rate of patients achieving joint response on Ulcerative Colitis-associated spondyloarthropathy
Measured: week 24
joint response and steroid free joint response
evaluate the rate of patients achieving joint response and steroid free joint response on Ulcerative Colitis-associated spondyloarthropathy
Measured: week 52
Secondary outcomes (11)
clinical intestinal response CIR
To assess the rate of patients achieving a clinical intestinal response CIR for Ulcerative Colitis
Measured: week 8
clinical intestinal response CIR
To assess the rate of patients achieving a clinical intestinal response CIR for Ulcerative Colitis
Measured: week 24
clinical intestinal response CIR
To assess the rate of patients achieving a clinical intestinal response CIR for Ulcerative Colitis
Measured: week 52
steroid free clinical intestinal remission
To assess the rate of patients achieving a steroid free clinical intestinal remission for Ulcerative Colitis
Measured: week 52
impact of Ulcerative Colitis
To assess the impact of Ulcerative Colitis and therapy with TOFA on Work Productivity and Activity Impairment through the administration of WPAI Questionnaire at baseline
Measured: week 8
impact of Ulcerative Colitis
To assess the impact of Ulcerative Colitis and therapy with TOFA on Work Productivity and Activity Impairment through the administration of WPAI Questionnaire at baseline
Measured: week 24
impact of Ulcerative Colitis
To assess the impact of Ulcerative Colitis and therapy with TOFA on Work Productivity and Activity Impairment through the administration of WPAI Questionnaire at baseline
Measured: week 52
health-related quality of life
To assess the health-related quality of life of the patients with the administration of the Short IBDQ at baseline
Measured: week 24 and 52
health-related quality of life
To assess the health-related quality of life of the patients with the administration of the Short IBDQ at baseline
Measured: week 52
adverse events
To report the rate of adverse events with TOFA
Measured: 24 month
redictors of joint response JR, steroid free joint response SFJR, clinical intestinal response CIR, and steroid free clinical intestinal remission SFCIR
To assess the predictors of joint response JR, steroid free joint response SFJR, clinical intestinal response CIR, and steroid free clinical intestinal remission SFCIR
Measured: 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2022
- Study start25 Apr 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05431283
- Sponsor's protocol ID
- 007
- Acronym
- RETUCAS
- Status last verified
- Jun 2022
- First submitted
- 6 Apr 2022
- Last updated
- 24 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacia Nel Mondo Reale di Tofacitinib Sulla Spondiloartropatia Associata Alla Colite Ulcerosa
- ClinicalTrials.gov ID
- NCT05431283
- Acronym / sponsor ID
- RETUCAS / 007
- Conditions
- Ulcerative Colitis, Spondyloarthropathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Italian Group for the study of Inflammatory Bowel Disease (IG-IBD)University, hospital or other
- Study start
- 25 Apr 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tofacitinib (TOFA) is a JAK inhibitor already used in rheumatology for the treatment of moderate-to-severe active rheumatoid arthritis and psoriatic arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease- modifying antirheumatic drugs. Furthermore, TOFA has been recently approved for the treatment of adult patients with moderate-to-severe active Ulcerative Colitis (UC) who had no response, lose response, or were intolerant to either conventional therapy or a biologic agent. The approval was based on the efficacy demonstrated by TOFA in three phase 3 randomized controlled trials named OCTAVE: two identically designed, 8-week, placebo- controlled, induction studies of oral TOFA 10 mg twice daily followed by the OCTAVE Sustain 52-week maintenance study. About sacroiliitis, 2 out of 8 patients treated with TOFA improved after 8 weeks, compared with 0 out of 3 patients in the placebo group. Obviously, these data should be interpreted with extreme caution since patient numbers were very low, and it should be again emphasized that these trials were not designed to explore the efficacy of TOFA onextraintestinal manifestations.
On these premises, we designed a prospective, multicenter, observational, 52-week study with the aim of assess the effectiveness of TOFA on UC-associated spondyloarthropathy.
Detailed description
Participants will receive TOFA at study entry (week 0) as treatment for UC according to standard clinical practice and recommended dosage of the drug, and will be followed up to 52 weeks. At baseline, all enrolled patients will undergo a detailed assessment including gender, age, duration of disease, smoking status, extension of disease (according to Montreal classification), clinical activity (assessed with the partial Mayo Score), C-Reactive Protein (CRP) values, faecal calprotectin, previous and concomitant therapies, data on SpA (axial vs. peripheral SpA, and assessment of ASDAS-CRP and/or DAS28-CRP scores). The joint response (JR), steroid free joint response (SFJR), clinical intestinal response (CIR), steroid free clinical intestinal remission (SFCIR), CRP and calprotectin values will be assessed at 8, 24 and 52 weeks (see further for the definitions of the outcomes). The burden of UC and therapy with TOFA on work productivity and health- related quality of life will be evaluated through the administration of the Work Productivity and Activity Impairment (WPAI) Questionnaire and the Short Inflammatory Bowel Disease Questionnaire Score (Short IBDQ), respectively, at baseline and at 24 and 52 weeks. The patients will be assessed with direct visits and biochemical evaluations, including monitoring of serum lipid levels, according to the routine clinical practice established for subjects treated with TOFA. The support by a rheumatologist is suggested in the clinical evaluation of patients All data will be collected anonymously in a specifically arranged eCRF form inside the IG-IBD registry.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients aged 18 years or older admitted at each IG-IBD center that agrees to participate could be be screened for inclusion
Key inclusion criteria (4 listed)
- An established diagnosis of UC and an established diagnosis of axial and/or peripheral SpA according to the Assessment of Spondyloarthritis international Society (ASAS) criteria
- Indication for treatment with TOFA as a therapy for UC according to the clinical practice and summary of product characteristics
- Active SpA at baseline assessed with an Ankylosing Spondylitis Disease Activity Score (ASDAS)-CRP ≥ 1.3 in case of axial SpA, and with a disease activity score (DAS)28-CRP ≥ 2.6 in case of peripheral SpA.
- Capability to express a written informed consent for the study
Key exclusion criteria (4 listed)
- Rheumatologic diseases other than UC-associated SpA (for example, previous diagnosis of rheumatoid arthritis or psoriatic arthritis)
- Inactive SpA at baseline
- Inability to understand or sign the informed consent
- Contraindications to treatment with TOFA (pregnancy, risk factors for venous thromboembolism, active infections, hepatic failure)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TofacitinibThis study aims to assess the effectiveness of TOFA | Drug | – |
Primary outcome
joint response and steroid free joint response
Time frame: week 8
evaluate the rate of patients achieving joint response and steroid free joint response on Ulcerative Colitis-associated spondyloarthropathy at week 8, 24, and 52
joint response and steroid free joint response
Time frame: week 24
evaluate the rate of patients achieving joint response on Ulcerative Colitis-associated spondyloarthropathy
joint response and steroid free joint response
Time frame: week 52
evaluate the rate of patients achieving joint response and steroid free joint response on Ulcerative Colitis-associated spondyloarthropathy
11 secondary outcomes
clinical intestinal response CIR
Time frame: week 8
clinical intestinal response CIR
Time frame: week 24
clinical intestinal response CIR
Time frame: week 52
steroid free clinical intestinal remission
Time frame: week 52
impact of Ulcerative Colitis
Time frame: week 8
impact of Ulcerative Colitis
Time frame: week 24
impact of Ulcerative Colitis
Time frame: week 52
health-related quality of life
Time frame: week 24 and 52
health-related quality of life
Time frame: week 52
adverse events
Time frame: 24 month
redictors of joint response JR, steroid free joint response SFJR, clinical intestinal response CIR, and steroid free clinical intestinal remission SFCIR
Time frame: 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Spondyloarthropathy, run by Italian Group for the study of Inflammatory Bowel Disease (IG-IBD) at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carola Lauritano (+393397793868, ctm@igibd.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
joint response and steroid free joint response (time frame: week 8). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.