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RCT to evaluate possible pharmacokinetic differences between the two current regimes of intensified adalimumab administration.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 80mg2w | Active Comparator | Adalimumab at an administration of 80 mg every two weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab | Drug | Monoclonal antibody used in IBD treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adalimumab trough level | Drug levels will be measured during 12 weeks of treatment | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Antibodies to Adalimumab (ADA) | Antibodies to Adalimumab will be tested for 12 weeks of treatment | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eduardo Martin Arranz, PhD | Contact | +34912071350 | emarranz@salud.madrid.org |
| Name | Affiliation | Role |
|---|---|---|
| Maria Dolores Martin Arranz, PhD | Hospital Universitario La Paz. IdiPaz. Universidad AutĂłnoma de Madrid. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario La Paz | Recruiting | Madrid | Madrd | 28046 | Spain |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| 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. | 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. | 12 weeks |
| Fecal calprotectin | Fecal calprotectin levels will be tested during the study | 12 weeks |
| Blood acute phase reactants | Blood acute phase reactants will be tested during the study | 12 weeks |
| QOL | Quality of life will be analysed using the Inflammatory Bowel Disease Questionnaire | 12 weeks |
| Treatment Satisfaction | Treatment Satisfaction Questionnaire for Medication (TSQM) | 12 weeks |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |