Status:
TERMINATED
Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
Crohn Disease
Ulcerative Colitis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
Loss of response of the Adalimumab biosimilar compared with the original drug.
Detailed Description
A single-site Unicentric, randomized, parallel-group, non-inferiority open study including patients diagnosed with inflammatory bowel disease (Crohn's disease and Ulcerative Colitis) who were in clini...
Eligibility Criteria
Inclusion
- Be male or female over 18 years of age
- Be a Patient with a previous confirmed diagnosis of Crohn´s disease an Ulcerative Colitis
- Previous treated with original Adalimumab for at least 6 months with regular maintenance dose (40 mg every 15 days) and in clinical and biological remission.
- Patients under treatment with intensified Adalimumab (40mg every 7 days or 80mg every 7 days) to maintain clinical and biological remission for at least 6 months.
- Patients with oral mesalazine with a stable dose for more than 30 days.
- Patients with immunosuppressive therapy (methotrexate, azathioprine) with a minimum intake time\> 60 days.
- Patients may be accepted with corticosteroids at the established doses:
- prednisone \<20mg / dl, budesonide \<9mg / dl.
- Patients who have a tuberculosis (TB) study (Mantoux / QuantiFERONTB test) updated in the last two year, with a negative result.
- Patient with serology hepatitis B and C, updated at the beginning of the treatment with Humira®
- Sign an informed consent document indicating that he/she understands the purpose of, and procedures required for, the study and are willing to participate in the study.
Exclusion
- Positive pregnancy test at the time of inclusion or during the follow-up period, as well as women who are breastfeeding
- Patients with uncontrolled comorbidities, active cancer, diabetes mellitus, severe cardiovascular disease, obstructive pulmonary disease, serious active infections.
- Patients with oral mesalazine initiated less than 30 days.
- Patients with immunosuppressive therapy (methotrexate, azathioprine) with a minimum intake time of \<60 days.
- Patient with original Adalimumab who do not meet a minimum of 6 months of stable dose (40 mg every 7 or 15 days)
- Patient on corticosteroid therapy at doses: prednisone\> 20mg / dl, budesonide = 9mg / dl, or with IV corticoids within 14 days prior screening date.
- Patients with mental disorders, alcohol / other substance abuse, or conditions that do not allow adherence to the study protocol.
- Patients with active TB
- Patients with defined Hepatitis B and C defined as:
- HBV: hepatitis B surface antigen (HbsAg) positive together with positive HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR). HCV: HCV ribonucleic acid (RNA) detectable in any patient with positive anti-HCV antibody (IgG)
Key Trial Info
Start Date :
October 10 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2020
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04131322
Start Date
October 10 2019
End Date
June 8 2020
Last Update
January 12 2021
Active Locations (1)
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1
Hospital Universitario Virgen Macarena
Seville, Spain, 41009