Primary ObjectiveThe primary objective of this study is to assess whether high ADA serum levels lead to more side effects compared to therapeutic ADA levels in CD and UC patients who are in clinical and biochemical remission.Secondary ObjectiveThe…
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is serum ADA trough level concentrations (the serum
concentration just before the next injection).
Secondary outcome
Secondary study parameters:
Secondary parameters are the skinscore, VAS-scores; Joint/Fatigue, the MFI,
SF-36, FACIT and IBDQ.
Other study parameters:
Clinical Colitis Activity/Harvey Bradshaw Index, serum TSH, vitamin D, Hb,
Leukocytes, Thrombocytes, CRP, Albumine and fecal calprotectin and baseline
variables like age, gender, treatment characteristics, anatomic distribution
and duration of disease.
Background summary
Adalimumab (Humira) is a monoclonal antibody that binds with tumor necrosis
factor (TNF). Treatment consists of a 40 mg subcutaneous injection every other
week. Adalimumab treatment is effective for inducing clinical remission in
patients with Crohn's disease (CD) and ulcerative colitis (UC) An optimal serum
ADA concentration window of 5-12 ug/ml has been proposed. Besides efficacy
concerns with low serum trough concentrations (the serum concentration just
before the next injection), hypothetically supra-therapeutic serum levels may
lead to safety concerns and side effects.
Paradoxically, patients treated with anti-TNF agents can experience other
immune mediated inflammatory disorders such as inflammatory skin lesions and
joint problems. Our clinical observation is that patients with supratherapeutic
levels often experience side effects, such as skin lesions, artralgia and
fatigue, which sometimes disappear after dose de-escalation. However, the
association of side effects of ADA with high ADA serum concentrations has not
been prospectively studied until date.
Study objective
Primary Objective
The primary objective of this study is to assess whether high ADA serum levels
lead to more side effects compared to therapeutic ADA levels in CD and UC
patients who are in clinical and biochemical remission.
Secondary Objective
The secondary objective is to describe the variation of ADA serum levels and
fecal Calprotectin levels at screening in IBD patients in clinical remission.
Study design
The design of the study is a single-centre, prospective, cross-sectional study.
The study is an observational study with non-invasive measurements. The setting
will be out-patients visiting the out-patient clinic of the Academic Medical
Center in Amsterdam.
Study burden and risks
Participation in this trial could result in one extra hospital visit if it is
not feasible to combine this study with a scheduled visit. At visit subject wil
be asked to complete a questionnaire and blood (6x 5ml tubes) and fecal sample
will be collected.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
IBD diagnose, in clinical and biochemical remission on adalimumab maintenance therapy
Exclusion criteria
-biochemical parameters contradicting complete remission. (high fecal calprotectin and CRP)
-conditions or co-morbidities which could potentially cause symptoms like, fatigue, joint pain and skin lesions (such as infectious disease, arthritis, malignancy or pregnancy).
-detectable anti-bodies to adalimumab,
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL48827.018.14 |