Trough level related side-effects of adalimumab therapy in patients with inflammatory bowel disease in clinical and biochemical remission, a cross-sectional cohort study

Trough level related side-effects of adalimumab therapy in patients with inflammatory bowel disease in clinical and biochemical remission, a cross-sectional cohort study - STADA: Side effects Trough level ADA

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON40963

Enrollment

Registered

2014-07-18

Start date

2014-08-13

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

inflammatory bowel disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: IBD diagnose, in clinical and biochemical remission on adalimumab maintenance therapy

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
The main study parameter is serum ADA trough level concentrations (the serum concentration just before the next injection).	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Netherlands

Outcome results