Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.

• Status: Terminated
• Trial end date: 2020-06-08
• Target enrollment: 0
• Participant gender: All

Summary

Loss of response of the Adalimumab biosimilar compared with the original drug.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Treatments: Adalimumab; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)