Inflammatory Bowel DiseasesPhase 3IntnsificADANCT04404517
Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks
A Phase 3 study testing Adalimumab in people with Inflammatory Bowel Diseases, run by Hospital Universitario La Paz at 1 site in Spain.
Trial summary
RCT to evaluate possible pharmacokinetic differences between the two current regimes of intensified adalimumab administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases
- What is being tested?
- Adalimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Oct 2019to 30 Oct 2021
- Phase
- Phase 3
- 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
- Patients > 18y
- Intensified adalimumab regime at least 4 weeks prior to enrollment.
- Immunosuppressants are allowed if a stable dose for > 12w is maintained.
- Corticosteroids are allowed if they were initiated prior to enrollment and a stable dose is maintained.
Who cannot join
- Patients unable to understand study protocol, study procedures or not capacitated to give informed consent.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario La Paz
Madrid, Madrd, 28046
Eduardo Martin Arranz, PhD, +34912071350, emarranz@salud.madrid.org
About this study
RCT to evaluate possible pharmacokinetic differences between the two current regimes of intensified adalimumab administration.
Read the detailed description
IBD patients in need of intensified adalimumab treatment will be randomized to receive 40mg sc weekly or 80mg sc every two weeks, and after 6 weeks of treatment each of the groups will be allocated to the other dosing regime. Adalimumab blood levels and other features such as specific drug antibodies and disease activity parameters will be compared between both groups.
- Conditions
- Inflammatory Bowel Diseases
- Being tested
- Adalimumab
- Keywords
- AntiTNF, Inflammatory Bowel Diseases, Adalimumab, Therapeutic drug monitoring
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdalimumabDrug
Monoclonal antibody used in IBD treatment
| Study group | Role | What they receive |
|---|---|---|
| 40mg1w | Active comparator | Adalimumab at an administration of 40 mg weekly for 6 weeks, followed by Adalimumab at an administration of 80 mg every two weeks Receives: Drug: Adalimumab |
| 80mg2w | Active comparator | Adalimumab at an administration of 80 mg every two weeks Receives: Drug: Adalimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adalimumab trough level
Drug levels will be measured during 12 weeks of treatment
Measured: 12 weeks
Secondary outcomes (8)
Antibodies to Adalimumab (ADA)
Antibodies to Adalimumab will be tested for 12 weeks of treatment
Measured: 12 weeks
Clinical response for Ulcerative Colitis
Simple Clinical Colitis Activity Index (SCCAI) (for UC) refers to disease symptoms during the previous week. It is composed of six domains. After recording, the clinician-based SCCAI is able to categorize two types of patients: patients with inactive disease (SCCAI<5) and patients with active disease (SCCAI≥5).
Measured: 12 weeks
Clinical response for Ulcerative colitis
Truelove Index (for UC), is composed of 6 variables. Clinical remission was defined as 1 or 2 stools per day without blood, absence of fever or tachycardia, a normal hemoglobin or "returning towards normal," a normal ESR or "returning towards normal," and gaining weight.
Measured: 12 weeks
Clinical response for Crohn´s Disease
Harvey-Bradshaw Index (for CD) considers five parameters. For each parameter a specific score is assigned. A score below 5 is considered as clinical remission. A reduction of 3 points is considered as relevant to define clinical response.
Measured: 12 weeks
Fecal calprotectin
Fecal calprotectin levels will be tested during the study
Measured: 12 weeks
Blood acute phase reactants
Blood acute phase reactants will be tested during the study
Measured: 12 weeks
QOL
Quality of life will be analysed using the Inflammatory Bowel Disease Questionnaire
Measured: 12 weeks
Treatment Satisfaction
Treatment Satisfaction Questionnaire for Medication (TSQM)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Oct 2019
- Primary completion30 Sep 2021 (estimated)
- Study completion30 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Paz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Dolores Martín Arranz, PhD, Hospital Universitario La Paz
- Investigators
- Maria Dolores Martin Arranz, PhD, Study director, Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04404517
- Sponsor's protocol ID
- IntnsificADA
- Acronym
- IntnsificADA
- Status last verified
- Jul 2021
- First submitted
- 16 Sep 2019
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks
- ClinicalTrials.gov ID
- NCT04404517
- Acronym / sponsor ID
- IntnsificADA / IntnsificADA
- Conditions
- Inflammatory Bowel Diseases
- Keywords
- AntiTNF, Inflammatory Bowel Diseases, Adalimumab, Therapeutic drug monitoring
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Universitario La PazUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Sep 2021 (estimated)
- Study completion
- 30 Oct 2021 (estimated)
- First posted
- 27 May 2020 (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.
RCT to evaluate possible pharmacokinetic differences between the two current regimes of intensified adalimumab administration.
Detailed description
IBD patients in need of intensified adalimumab treatment will be randomized to receive 40mg sc weekly or 80mg sc every two weeks, and after 6 weeks of treatment each of the groups will be allocated to the other dosing regime. Adalimumab blood levels and other features such as specific drug antibodies and disease activity parameters will be compared between both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 40mg1w | Active comparator | Drug: AdalimumabAdalimumab at an administration of 40 mg weekly for 6 weeks, followed by Adalimumab at an administration of 80 mg every two weeks |
| 80mg2w | Active comparator | Drug: AdalimumabAdalimumab at an administration of 80 mg every two weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients > 18y
- Intensified adalimumab regime at least 4 weeks prior to enrollment.
- Immunosuppressants are allowed if a stable dose for > 12w is maintained.
- Corticosteroids are allowed if they were initiated prior to enrollment and a stable dose is maintained.
Key exclusion criteria (2 listed)
- Patients unable to understand study protocol, study procedures or not capacitated to give informed consent.
- Pregnant or lactating women.
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 |
|---|---|---|
| AdalimumabMonoclonal antibody used in IBD treatment | Drug | 40mg1w, 80mg2w |
Primary outcome
Adalimumab trough level
Time frame: 12 weeks
Drug levels will be measured during 12 weeks of treatment
8 secondary outcomes
Antibodies to Adalimumab (ADA)
Time frame: 12 weeks
Clinical response for Ulcerative Colitis
Time frame: 12 weeks
Clinical response for Ulcerative colitis
Time frame: 12 weeks
Clinical response for Crohn´s Disease
Time frame: 12 weeks
Fecal calprotectin
Time frame: 12 weeks
Blood acute phase reactants
Time frame: 12 weeks
QOL
Time frame: 12 weeks
Treatment Satisfaction
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Individual participant dataSharing planned: No
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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.
Maria Dolores Martin Arranz, PhD study director
Hospital Universitario La Paz. IdiPaz. Universidad Autónoma de Madrid.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Adalimumab in people with Inflammatory Bowel Diseases, run by Hospital Universitario La Paz at 1 site in Spain.
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 2 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 23 Jul 2021. 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 Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Eduardo Martin Arranz, PhD (+34912071350, emarranz@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adalimumab trough level (time frame: 12 weeks). 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 23 Jul 2021.