Trials / Unknown
UnknownNCT04404517
Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Hospital Universitario La Paz · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Adalimumab | Monoclonal antibody used in IBD treatment |
Timeline
- Start date
- 2019-10-01
- Primary completion
- 2021-09-30
- Completion
- 2021-10-30
- First posted
- 2020-05-27
- Last updated
- 2021-07-23
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT04404517. Inclusion in this directory is not an endorsement.