oss of response of the Adalimumba biosimilar compared with the original drug

Phase 1

• Conditions: Inflammatory Bowel Disease: Crohn's Disease and Ulcerative Colitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2019-000717-37-ES
• Lead Sponsor: Fundación Publica Andaluza para la Gestión de Salud en Sevilla (FISEVI)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-28
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 136

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 / QuantiFERON-TB test) updated in the last two year, with a negative result.
- Patient with serology hepatitis B and C, updated at the begining 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 116
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

-Pregnant or nursing women
- 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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified