- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02998398
Evaluation of the Switch From the Original Infliximab to Its Biosimilar in Daily Practice at Cochin Hospital (SIC)
Evaluation of the Switch From the Original Infliximab ( REMICADE®) to Its Biosimilar (INFLECTRA®) in Daily Practice at Cochin Hospital
Study Overview
Status
Intervention / Treatment
Detailed Description
All patients managed in one of the departments of cochin Hospital who are receiving the original infliximab ( REMICADE®) from at least 4 months will be invited to continue to receive infliximab but using its biosimilar (INFLECTRA®)) at the same regimen (identical dose per infusion and interval between two infusions) than the previous one while receiving REMICADE®. The tolerability of the infusion will be recorded as well as the percentage of patients continuing INFLECTRA® after at least six months of its initiation.
Moreover, the infliximab serum level will be evaluated after the last infusion of REMICADE® and after the third infusion of INFLECTRA®. At the same time, anti-drug antibodies will be tested.
Finally for each of the underlying disease (e.g. rheumatoid arthritis, spondyloarthritis, Crohn's disease, uveitis,..), the maintenance of the efficacy of Infliximab will be evaluated according to the usual outcome measures of the activity of the disease
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75014
- Hôpital COCHIN
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Male or female over 18 year old
- Patient treated with REMICADE® in Cochin hospital
- More than 3 perfusions of REMICADE® before the switch to INFLECTRA®
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of patients continuing INFLECTRA®
Time Frame: after the third infusion of INFLECTRA®, up to 24 weeks
|
Evaluation of the percentage of patients continuing INFLECTRA® after its third infusion
|
after the third infusion of INFLECTRA®, up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Infliximab serum level
Time Frame: after the third infusion of INFLECTRA®, up to 24 weeks
|
after the third infusion of INFLECTRA®, up to 24 weeks
|
|
Percentage of patients with a flare of their disease
Time Frame: after the third infusion of INFLECTRA®, up to 24 weeks
|
The flare will be assessed by usual physiological parameter of the disease
|
after the third infusion of INFLECTRA®, up to 24 weeks
|
Percentage of patients with anti-drug antibodies assessed after the third infusion of INFLECTRA®
Time Frame: after the third infusion of INFLECTRA®, up to 24 weeks
|
after the third infusion of INFLECTRA®, up to 24 weeks
|
|
Percentage of patients with anti drug antibodies assessed after the last infusion of REMICADE®
Time Frame: after the last infusion of REMICADE®, up to 24 weeks
|
after the last infusion of REMICADE®, up to 24 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Maxime DOUGADOS, MD, PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Infections
- Eye Diseases
- Gastrointestinal Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Gastroenteritis
- Arthritis
- Intestinal Diseases
- Uveal Diseases
- Spinal Diseases
- Bone Diseases
- Inflammatory Bowel Diseases
- Bone Diseases, Infectious
- Crohn Disease
- Uveitis
- Spondylitis
- Spondylarthritis
- Antirheumatic Agents
- Gastrointestinal Agents
- Dermatologic Agents
- Infliximab
Other Study ID Numbers
- NI-16-004
- 2016-A02016-A00700-51 (OTHER: ANSM)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Rheumatoid Arthritis
-
Janssen Research & Development, LLCWithdrawnActive Rheumatoid Arthritis; Rheumatoid Arthritis
-
Centocor, Inc.CompletedRheumatoid Arthritis, Juvenile
-
AmgenTerminated
-
Children's Hospital Medical Center, CincinnatiNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)CompletedJuvenile Rheumatoid ArthritisUnited States
-
AmgenImmunex CorporationCompletedJuvenile Rheumatoid Arthritis
-
Assistance Publique - Hôpitaux de ParisSociete Francaise de RhumatologieRecruiting
-
Amsterdam UMC, location VUmcEuropean CommissionCompletedRheumatoId ArthritisNetherlands, Germany, Portugal, Italy, Hungary, Romania, Slovakia
-
University Hospital, ToulouseCompletedRheumatoId ArthritisFrance
-
David Grant U.S. Air Force Medical CenterCompleted
-
TcLand Expression S.A.European CommissionTerminatedRheumatoId ArthritisFrance, Netherlands, Turkey, Czechia, Israel
Clinical Trials on Switch from REMICADE® to INFLECTRA®
-
Universitaire Ziekenhuizen KU LeuvenRecruiting
-
Juul Labs, Inc.CompletedTobacco Use | Tobacco Smoking | Electronic Cigarette Use | Cigarette Use, ElectronicUnited States
-
National Institute on Media and the FamilyUniversity of Minnesota; Michigan State University; Iowa State University; Cargill and other collaboratorsCompletedObesity | OverweightUnited States
-
TcLand Expression S.A.European CommissionTerminatedRheumatoId ArthritisFrance, Netherlands, Turkey, Czechia, Israel
-
Assistance Publique - Hôpitaux de ParisRevenio ResearchRecruitingHealthy, Wheezing, Non Wheezing Acute Respiratory EpisodeFrance
-
Mackay Memorial HospitalCompleted
-
University of South FloridaCompletedObesity | Insomnia | Weight Loss | Sleep Disordered Breathing | PostpartumUnited States
-
AmgenCompletedArthritis, RheumatoidUnited States, Spain, Australia, Bulgaria, Germany, Poland, Canada, Czechia, Hungary
-
Centre de Recherches et d'Etude sur la Pathologie...Active, not recruiting
-
Hospital Universitari de BellvitgeCompleted