Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease.
NCT04131322 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2021-01-12
Summary
Loss of response of the Adalimumab biosimilar compared with the original drug.
Conditions
- Crohn Disease
- Ulcerative Colitis
Interventions
- DRUG
-
Amgevita 40Mg Solution for Injection
Adalimumab 40Mg Solution for Injection
- DRUG
-
HUMIRA 40Mg Solution for Injection
Adalimumab 40Mg Solution for Injection
Sponsors & Collaborators
-
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
lead OTHER
Principal Investigators
-
Federico Argüelles Arias, Md PhD · Universitary Hospital Virgen Macarena
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-10
- Primary Completion
- 2020-06-08
- Completion
- 2020-06-08
Countries
- Spain
Study Locations
More Related Trials
-
Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
NCT00195715 ·Status: COMPLETED ·Phase: PHASE3
-
A Long-Term Registry of Humira® (Adalimumab) in Subjects With Moderately to Severely Active Crohn's Disease (CD)
NCT00524537 ·Status: COMPLETED
-
Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
NCT00105300 ·Status: COMPLETED ·Phase: PHASE3
-
Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease
NCT02148718 ·Status: COMPLETED ·Phase: PHASE4
-
Adalimumab for the Induction and Maintenance of Clinical Remission in Subjects With Crohn's Disease
NCT00077779 ·Status: COMPLETED ·Phase: PHASE3
-
Open-Label Adalimumab for Ulcerative Colitis Patients
NCT00421642 ·Status: COMPLETED ·Phase: PHASE1
-
Remission in Subjects With Crohn's Disease, 1 Year Phase
NCT00055497 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
NCT02065622 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate the Safety and Efficacy of Adalimumab in Chinese Subjects With Moderate to Severe Crohn's Disease
NCT02499783 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis
NCT00408629 ·Status: COMPLETED ·Phase: PHASE3
-
Correlation of Serum Adalimumab Levels at an Administration of 40 mg Weekly vs 80 mg Every Two Weeks
NCT04404517 ·Status: UNKNOWN ·Phase: PHASE3
-
Remission in Subjects With Crohn's Disease, Open Label Extension
NCT01070303 ·Status: COMPLETED ·Phase: PHASE3
-
Human Anti-TNF Monoclonal Antibody Adalimumab in Canadian Subjects With Moderate to Severe Crohn's Disease (ACCESS)
NCT00427921 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of the Human Anti-TNF Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
NCT00055523 ·Status: COMPLETED ·Phase: PHASE2
-
Comparison of Vedolizumab Treatment to Adalimumab Dose Intensification in Crohn's Disease Patients With Loss of Response or Biomarker Activity to Adalimumab on First Line With Therapeutic Drug Concentration.
NCT06180382 ·Status: RECRUITING ·Phase: PHASE4
-
A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease
NCT04655807 ·Status: WITHDRAWN ·Phase: PHASE2
-
Study of the Efficacy and Safety of AMT-101 in Combination With Adalimumab in Subjects With Ulcerative Colitis (MARKET)
NCT05372939 ·Status: COMPLETED ·Phase: PHASE2
-
Switching From Adalimumab to Infliximab
NCT01338740 ·Status: COMPLETED
-
A Study of Subcutaneous HUMIRA (Adalimumab) Injection to Assess Adverse Events and Change in Disease Activity In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)
NCT05394805 ·Status: COMPLETED
-
Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine
NCT01083680 ·Status: COMPLETED
-
Long-term Open-label Safety and Efficacy Study of Adalimumab in Subjects With Ulcerative Colitis
NCT00573794 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis
NCT00385736 ·Status: COMPLETED ·Phase: PHASE3
-
Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease
NCT02065570 ·Status: COMPLETED ·Phase: PHASE3
-
A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
NCT01848561 ·Status: ACTIVE_NOT_RECRUITING
-
Evaluate if Response to Infliximab or Adalimumab May be Regained With an Immunomodulator
NCT02413047 ·Status: TERMINATED ·Phase: NA