Crohn Disease in RemissionPhase 4LADINCT03172377
Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease Patients
A Phase 4 study testing Lengthening adalimumab dosing interval in people with Crohn Disease in Remission and Crohn Disease, run by Radboud University Medical Center at 22 sites in Netherlands.
Trial summary
Crohn's disease is a chronic inflammatory bowel disease. This disease can be treated with, among other things, biologicals such as adalimumab. Patients use adalimumab for a long time to maintain remission and to prevent relapse of the bowel inflammation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease in Remission, Crohn Disease
- What is being tested?
- Lengthening adalimumab dosing interval
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 22 sitesNetherlands
- Study dates
- 3 May 2017to Oct 2022
- Phase
- Phase 4
- 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
Who may be able to join
- Diagnosis of colonic and/or distal ileal CD
- Sustained steroid-free clinical remission for >9 months whilst being treated with adalimumab at a stable dose
- Adalimumab dosed at 40 mg sc every 2 weeks
- Full clinical response and disease control, all three criteria below need to be fulfilled prior to enrollment:
- Absence of active inflammatory intestinal or extra-intestinal symptoms, as judged by both patient and physician
- Fecal calprotectin (FC) < 150 μg/g and C reactive protein (CRP) <10 mg/L
- Harvey Bradshaw Index (HBI) <5
Who cannot join
- Absence of written informed consent
- Concomitant corticosteroid usage
- Need for CD-related surgery
- Actively draining peri-anal fistula
- Pregnancy or lactation
- Other significant medical conditions that might interfere with this study (such as current/recent malignancy, immunodeficiency syndromes and psychiatric illness)
- Impossibility to measure outcomes, e.g. planned relocation, language issues, short life expectancy
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Netherlands22 sites
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, North Brabant, PO box 90153, 5200 ME
Flevoziekenhuis
Almere Stad
VU Medisch Centrum
Amsterdam, North Holland
AmsterdamUMC - location AMC
Amsterdam
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam
Amphia Ziekenhuis
Breda, North Brabant, PO box 90157, 4800 RL
Reinier de Graaf
Delft
Albert Schweitzer Ziekenhuis
Dordrecht, South Holland, PO box 444, 3300 AK
Maxima Medisch Centrum
Eindhoven
Medisch Spectrum Twente
Enschede
Zuyderland ziekenhuis
Geleen
Spaarne Gasthuis
Haarlem
Leids Universitair Medisch Centrum
Leiden
Maastricht UMC+
Maastricht
Radboudumc University Nijmegen Medical Centre
Nijmegen, Gelderland, 6500 HB
Canisius Wilhelmina Ziekenhuis
Nijmegen
Franciscus Gasthuis & Vlietland
Rotterdam, South Holland, PO box 10900, 3004 BA
Erasmus Medical Center
Rotterdam, South Holland, PO box 2040, 3000 CA
Ikazia Ziekenhuis
Rotterdam, South Holland, PO box 5009, 3008 AA
Elisabeth-TweeSteden Ziekenhuis
Tilburg
Bernhoven
Uden, North Brabant, PO box 707, 5400 AS
UMC Utrecht
Utrecht, PO box 85500, 3508 GA
About this study
Crohn's disease is a chronic inflammatory bowel disease. This disease can be treated with, among other things, biologicals such as adalimumab. Patients use adalimumab for a long time to maintain remission and to prevent relapse of the bowel inflammation. The disadvantages of this therapy are the high price and side effects (such as the higher risk of infection).
Currently, adalimumab is given every 2 weeks, by injection under the skin. The optimal time between two injections has never been investigated before. Prior research in patients with rheumatoid arthritis shows that disease remission can be maintained with longer injection-intervals. Our hypothesis is that this is the same for Crohn's disease patients. Our aim is to show non-inferiority of extending the adalimumab dosing interval, under strict disease monitoring in Crohn's disease patients in sustained (>9 months) clinical remission, compared to standard care.
During the trial,174 patients with stable Crohn's disease will be divided into 2 groups. One group continues adalimumab injections with the same 2-week interval. And the other group will incrementally extend the interval to 4 weeks, under strict disease monitoring. If a step-down leads to recurrence of disease activity patients will return to the preceding effective dosing interval. Thus, we will investigate whether, and for whom, it is safe to extend the adalimumab injection interval.
Read the detailed description
Rationale
Adalimumab is both an effective induction and maintenance therapy for Crohn's disease (CD). Due to the risk of side effects (infections, injection reaction) and high costs, an extension of the injection interval is an attractive option. However, this strategy has not been evaluated yet in a randomized controlled trial in CD patients.
Objective
To assess non-inferiority and cost-effectiveness of disease activity guided adalimumab interval lengthening in CD patients in sustained (>9 months) clinical remission, compared to standard dosing of every other week.
Study design
Multicenter, randomized controlled, open label non-inferiority trial, with two treatment arms.
Study population
Crohn's disease patients, in sustained clinical remission on adalimumab maintenance therapy.
Intervention
Intervention arm: The adalimumab injection interval during maintenance therapy (40 mg per 2 weeks) will be extended through a stepwise disease activity guided manner to 3 weeks and subsequently - after 24 weeks - to 4 weeks. If a step-down leads to recurrence of disease activity patients will return to the preceding effective dosing interval.
Control arm: patients will continue adalimumab maintenance treatment of 40mg per 2 weeks. Treatment decisions are made at the discretion of the treating physician.
Main study parameters/endpoints
Primary outcome: Cumulative incidence of persistent disease flares in 48 weeks of follow-up. A persistent flare is defined as two of three of the following criteria persisting for > 8 weeks, despite dose escalation of adalimumab; FC >250 µg/g, CRP≥10 mg/L, HBI ≥5. Non-inferiority is reached if the difference in cumulative incidence of persistent flares not exceeds the non-inferiority margin of 15%.
Secondary outcomes include cumulative incidence of transient flares, adverse events, predictors for successful dose reduction and cost-effectiveness.
- Conditions
- Crohn Disease in Remission, Crohn Disease
- Being tested
- Lengthening adalimumab dosing interval
- Keywords
- adalimumab, anti-tumor necrosis factor, anti-TNF, Humira, interval lengthening, dosing interval, inflammatory bowel disease, antidrug antibodies, trough levels, pharmacokinetics, immunogenicity, cost-effectiveness, dose reduction
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lengthening adalimumab dosing intervalOther
Also called Lengthening Humira dosing interval, Longer adalimumab interval, Longer Humira interval, Adalimumab dose reduction
Lengthening adalimumab dosing interval from 2 weeks to 3 weeks and -later- to 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Lengthening adalimumab dosing interval: The adalimumab injection interval during maintenance therapy (40 mg sc / 2 weeks) will be extended through a stepwise disease activity guided manner to 3 weeks and subsequently - after 24 weeks - to 4 weeks. If a step-down leads to recurrence of disease activity patients will return to the preceding effective dosing interval. Receives: Other: Lengthening adalimumab dosing interval |
| Control group | No intervention | Standard care: patients will continue adalimumab maintenance treatment of 40mg per 2 weeks. Treatment decisions are made at the discretion of the treating physician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of persistent disease flares.
A persistent flare is defined as two of three of the following criteria persisting for > 8 weeks, despite dose escalation of adalimumab; FC >250 µg/g, CRP≥10 mg/L, HBI ≥5. Non-inferiority is reached if the difference in cumulative incidence of persistent flares not exceeds the non-inferiority margin of 15%.
Measured: From the date of randomization up to week 48.
Secondary outcomes (6)
Cumulative incidence of transient disease flares.
A transient flare is defined as two of three of the following criteria persisting for ≤ 8 weeks; FC >250 µg/g, CRP≥10 mg/L, HBI ≥5.
Measured: From the date of randomization up to week 48.
(Serious) adverse event rate
(Serious) adverse events that are (possibly) related to adalimumab and the (Serious) adverse events that are (possibly) related to adalimumab interval lengthening in the intervention and control group, expressed as events/ 100 patient-years of follow-up.
Measured: From the date of randomization up to week 48.
Whether adalimumab drug level is associated with successful interval lengthening
Adalimumab drug levels at baseline measured by ELISA.
Measured: From the date of randomization up to week 48.
Whether biochemic FC or CRP are associated with successful interval lengthening
Fecal calprotectin (mg/kg) or C-reactive protein (mg/L).
Measured: From the date of randomization up to week 48.
Whether co-medication use is associated with successful interval lengthening
Co-medication includes azathioprine, Co-medication includes azathioprine, 6-mercaptopurine, 6-thioguanine, methotrexate.
Measured: From the date of randomization up to week 48.
The decremental cost effectiveness ratio of this interval lengthening strategy
Dividing the difference in costs (based on medical consumption (by medical consumption questionnaire(MCQ)) and work productivity (by productivity cost questionnaire(PCQ))) by the difference in quality-adjusted life years (based on EuroQol-5D questionnaire).
Measured: From the date of randomization up to week 48.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start3 May 2017
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Crohn Disease in RemissionStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicenter, randomized controlled, open label non-inferiority trial
- Masking
- None (open label)
- Enrolment
- 174 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Dr. Hoentjen, MD, PhD, Principal investigator, Radboud University Medical CenterProf. dr. van der Woude, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172377
- Sponsor's protocol ID
- NL58948.091.16
- Other IDs
- 848015002, 2016-003321-42, 2016
- Acronym
- LADI
- Status last verified
- Nov 2021
- First submitted
- 29 May 2017
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
van Linschoten RCA, Jansen FM, Pauwels RWM, Smits LJT, Atsma F, Kievit W, de Jong DJ, de Vries AC, Boekema PJ, West RL, Bodelier AGL, Gisbertz IAM, Wolfhagen FHJ, Romkens TEH, Lutgens MWMD, van Bodegraven AA, Oldenburg B, Pierik MJ, Russel MGVM, de Boer NK, Mallant-Hent RC, Ter Borg PCJ, van der Meulen-de Jong AE, Jansen JM, Jansen SV, Tan ACITL, van der Woude CJ, Hoentjen F; LADI study group, the Dutch Initiative on Crohn, Colitis (ICC). A Prediction Model for Successful Increase of Adalimumab Dose Intervals in Patients with Crohn's Disease: Secondary Analysis of the Pragmatic Open-Label Randomised Controlled Non-inferiority LADI Trial. Dig Dis Sci. 2024 Jun;69(6):2165-2174. doi: 10.1007/s10620-024-08410-z. Epub 2024 Apr 9.
PubMed 38594435Jansen FM, van Linschoten RCA, Kievit W, Smits LJT, Pauwels RWM, de Jong DJ, de Vries AC, Boekema PJ, West RL, Bodelier AGL, Gisbertz IAM, Wolfhagen FHJ, Romkens TEH, Lutgens MWMD, van Bodegraven AA, Oldenburg B, Pierik MJ, Russel MGVM, de Boer NK, Mallant-Hent RC, Ter Borg PCJ, van der Meulen-de Jong AE, Jansen JM, Jansen SV, Tan ACITL, Hoentjen F, van der Woude CJ; LADI study group. Cost-Effectiveness Analysis of Increased Adalimumab Dose Intervals in Crohn's Disease Patients in Stable Remission: The Randomized Controlled LADI Trial. J Crohns Colitis. 2023 Nov 24;17(11):1771-1780. doi: 10.1093/ecco-jcc/jjad101.
PubMed 37310877van Linschoten RCA, Jansen FM, Pauwels RWM, Smits LJT, Atsma F, Kievit W, de Jong DJ, de Vries AC, Boekema PJ, West RL, Bodelier AGL, Gisbertz IAM, Wolfhagen FHJ, Romkens TEH, Lutgens MWMD, van Bodegraven AA, Oldenburg B, Pierik MJ, Russel MGVM, de Boer NK, Mallant-Hent RC, Ter Borg PCJ, van der Meulen-de Jong AE, Jansen JM, Jansen SV, Tan ACITL, van der Woude CJ, Hoentjen F; LADI study group and the Dutch Initiative on Crohn and Colitis. Increased versus conventional adalimumab dose interval for patients with Crohn's disease in stable remission (LADI): a pragmatic, open-label, non-inferiority, randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Apr;8(4):343-355. doi: 10.1016/S2468-1253(22)00434-4. Epub 2023 Jan 31.
PubMed 36736339Smits LJT, Pauwels RWM, Kievit W, de Jong DJ, de Vries AC, Hoentjen F, van der Woude CJ; LADI study group. Lengthening adalimumab dosing interval in quiescent Crohn's disease patients: protocol for the pragmatic randomised non-inferiority LADI study. BMJ Open. 2020 May 26;10(5):e035326. doi: 10.1136/bmjopen-2019-035326.
PubMed 32461297
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lengthening Adalimumab Dosing Interval in Quiescent Crohn's Disease Patients
- ClinicalTrials.gov ID
- NCT03172377
- Acronym / sponsor ID
- LADI / NL58948.091.16
- Conditions
- Crohn Disease in Remission, Crohn Disease
- Keywords
- adalimumab, anti-tumor necrosis factor, anti-TNF, Humira, interval lengthening, dosing interval, inflammatory bowel disease, antidrug antibodies
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 174 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- 3 May 2017 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 1 Jun 2017 (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.
Crohn's disease is a chronic inflammatory bowel disease. This disease can be treated with, among other things, biologicals such as adalimumab. Patients use adalimumab for a long time to maintain remission and to prevent relapse of the bowel inflammation. The disadvantages of this therapy are the high price and side effects (such as the higher risk of infection).
Currently, adalimumab is given every 2 weeks, by injection under the skin. The optimal time between two injections has never been investigated before. Prior research in patients with rheumatoid arthritis shows that disease remission can be maintained with longer injection-intervals. Our hypothesis is that this is the same for Crohn's disease patients. Our aim is to show non-inferiority of extending the adalimumab dosing interval, under strict disease monitoring in Crohn's disease patients in sustained (>9 months) clinical remission, compared to standard care.
During the trial,174 patients with stable Crohn's disease will be divided into 2 groups. One group continues adalimumab injections with the same 2-week interval. And the other group will incrementally extend the interval to 4 weeks, under strict disease monitoring. If a step-down leads to recurrence of disease activity patients will return to the preceding effective dosing interval. Thus, we will investigate whether, and for whom, it is safe to extend the adalimumab injection interval.
Detailed description
Rationale
Adalimumab is both an effective induction and maintenance therapy for Crohn's disease (CD). Due to the risk of side effects (infections, injection reaction) and high costs, an extension of the injection interval is an attractive option. However, this strategy has not been evaluated yet in a randomized controlled trial in CD patients.
Objective
To assess non-inferiority and cost-effectiveness of disease activity guided adalimumab interval lengthening in CD patients in sustained (>9 months) clinical remission, compared to standard dosing of every other week.
Study design
Multicenter, randomized controlled, open label non-inferiority trial, with two treatment arms.
Study population
Crohn's disease patients, in sustained clinical remission on adalimumab maintenance therapy.
Intervention
Intervention arm: The adalimumab injection interval during maintenance therapy (40 mg per 2 weeks) will be extended through a stepwise disease activity guided manner to 3 weeks and subsequently - after 24 weeks - to 4 weeks. If a step-down leads to recurrence of disease activity patients will return to the preceding effective dosing interval.
Control arm: patients will continue adalimumab maintenance treatment of 40mg per 2 weeks. Treatment decisions are made at the discretion of the treating physician.
Main study parameters/endpoints
Primary outcome: Cumulative incidence of persistent disease flares in 48 weeks of follow-up. A persistent flare is defined as two of three of the following criteria persisting for > 8 weeks, despite dose escalation of adalimumab; FC >250 µg/g, CRP≥10 mg/L, HBI ≥5. Non-inferiority is reached if the difference in cumulative incidence of persistent flares not exceeds the non-inferiority margin of 15%.
Secondary outcomes include cumulative incidence of transient flares, adverse events, predictors for successful dose reduction and cost-effectiveness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, randomized controlled, open label non-inferiority trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Lengthening adalimumab dosing intervalLengthening adalimumab dosing interval: The adalimumab injection interval during maintenance therapy (40 mg sc / 2 weeks) will be extended through a stepwise disease activity guided manner to 3 weeks and subsequently - after 24 weeks - to 4 weeks. If a step-down leads to recurrence of disease activity patients will return to the preceding effective dosing interval. |
| Control group | No intervention | –Standard care: patients will continue adalimumab maintenance treatment of 40mg per 2 weeks. Treatment decisions are made at the discretion of the treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Diagnosis of colonic and/or distal ileal CD
- Sustained steroid-free clinical remission for >9 months whilst being treated with adalimumab at a stable dose
- Adalimumab dosed at 40 mg sc every 2 weeks
- Full clinical response and disease control, all three criteria below need to be fulfilled prior to enrollment:
Key exclusion criteria (7 listed)
- Absence of written informed consent
- Concomitant corticosteroid usage
- Need for CD-related surgery
- Actively draining peri-anal fistula
- Pregnancy or lactation
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 |
|---|---|---|
| Lengthening adalimumab dosing intervalAlso: Lengthening Humira dosing interval, Longer adalimumab interval, Longer Humira interval, Adalimumab dose reductionLengthening adalimumab dosing interval from 2 weeks to 3 weeks and -later- to 4 weeks. | Other | Intervention group |
Primary outcome
Cumulative incidence of persistent disease flares.
Time frame: From the date of randomization up to week 48.
A persistent flare is defined as two of three of the following criteria persisting for > 8 weeks, despite dose escalation of adalimumab; FC >250 µg/g, CRP≥10 mg/L, HBI ≥5. Non-inferiority is reached if the difference in cumulative incidence of persistent flares not exceeds the non-inferiority margin of 15%.
6 secondary outcomes
Cumulative incidence of transient disease flares.
Time frame: From the date of randomization up to week 48.
(Serious) adverse event rate
Time frame: From the date of randomization up to week 48.
Whether adalimumab drug level is associated with successful interval lengthening
Time frame: From the date of randomization up to week 48.
Whether biochemic FC or CRP are associated with successful interval lengthening
Time frame: From the date of randomization up to week 48.
Whether co-medication use is associated with successful interval lengthening
Time frame: From the date of randomization up to week 48.
The decremental cost effectiveness ratio of this interval lengthening strategy
Time frame: From the date of randomization up to week 48.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Derived from this study: PubMed 38594435van Linschoten RCA, Jansen FM, Pauwels RWM, Smits LJT, Atsma F, Kievit W, de Jong DJ, de Vries AC, Boekema PJ, West RL, Bodelier AGL, Gisbertz IAM, Wolfhagen FHJ, Romkens TEH, Lutgens MWMD, van Bodegraven AA, Oldenburg B, Pierik MJ, Russel MGVM, de Boer NK, Mallant-Hent RC, Ter Borg PCJ, van der Meulen-de Jong AE, Jansen JM, Jansen SV, Tan ACITL, van der Woude CJ, Hoentjen F; LADI study group, the Dutch Initiative on Crohn, Colitis (ICC). A Prediction Model for Successful Increase of Adalimumab Dose Intervals in Patients with Crohn's Disease: Secondary Analysis of the Pragmatic Open-Label Randomised Controlled Non-inferiority LADI Trial. Dig Dis Sci. 2024 Jun;69(6):2165-2174. doi: 10.1007/s10620-024-08410-z. Epub 2024 Apr 9.
- Derived from this study: PubMed 37310877Jansen FM, van Linschoten RCA, Kievit W, Smits LJT, Pauwels RWM, de Jong DJ, de Vries AC, Boekema PJ, West RL, Bodelier AGL, Gisbertz IAM, Wolfhagen FHJ, Romkens TEH, Lutgens MWMD, van Bodegraven AA, Oldenburg B, Pierik MJ, Russel MGVM, de Boer NK, Mallant-Hent RC, Ter Borg PCJ, van der Meulen-de Jong AE, Jansen JM, Jansen SV, Tan ACITL, Hoentjen F, van der Woude CJ; LADI study group. Cost-Effectiveness Analysis of Increased Adalimumab Dose Intervals in Crohn's Disease Patients in Stable Remission: The Randomized Controlled LADI Trial. J Crohns Colitis. 2023 Nov 24;17(11):1771-1780. doi: 10.1093/ecco-jcc/jjad101.
- Derived from this study: PubMed 36736339van Linschoten RCA, Jansen FM, Pauwels RWM, Smits LJT, Atsma F, Kievit W, de Jong DJ, de Vries AC, Boekema PJ, West RL, Bodelier AGL, Gisbertz IAM, Wolfhagen FHJ, Romkens TEH, Lutgens MWMD, van Bodegraven AA, Oldenburg B, Pierik MJ, Russel MGVM, de Boer NK, Mallant-Hent RC, Ter Borg PCJ, van der Meulen-de Jong AE, Jansen JM, Jansen SV, Tan ACITL, van der Woude CJ, Hoentjen F; LADI study group and the Dutch Initiative on Crohn and Colitis. Increased versus conventional adalimumab dose interval for patients with Crohn's disease in stable remission (LADI): a pragmatic, open-label, non-inferiority, randomised controlled trial. Lancet Gastroenterol Hepatol. 2023 Apr;8(4):343-355. doi: 10.1016/S2468-1253(22)00434-4. Epub 2023 Jan 31.
- Derived from this study: PubMed 32461297Smits LJT, Pauwels RWM, Kievit W, de Jong DJ, de Vries AC, Hoentjen F, van der Woude CJ; LADI study group. Lengthening adalimumab dosing interval in quiescent Crohn's disease patients: protocol for the pragmatic randomised non-inferiority LADI study. BMJ Open. 2020 May 26;10(5):e035326. doi: 10.1136/bmjopen-2019-035326.
- Dutch organisation for healthcare research and innovation (ZonMW)Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Dr. Hoentjen, MD, PhD principal investigator
Radboud University Medical Center
Prof. dr. van der Woude, MD, PhD principal investigator
Erasmus Medical Center
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lengthening adalimumab dosing interval in people with Crohn Disease in Remission and Crohn Disease, run by Radboud University Medical Center at 22 sites in Netherlands.
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 7 inclusion and 7 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 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Netherlands. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of persistent disease flares. (time frame: From the date of randomization up to week 48.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03172377, which also lists 4 linked publications.
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 14 Oct 2022.