Topics

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

2019-10-24 12:49:52 | BioPortfolio

Summary

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

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 clinical remission with Adalimumab original for at least 6 months prior to the start of the study.

A total of 216 patients with inflammatory bowel disease from the Inflammatory Unit of the Virgin Macarena University Hospital will be randomized 1:1 to receive the study drug, Adalimumab biosimilar (AMGEVITA®) subcutaneous 40mg every 15 days or maintain the original drug (Humira®) 40 mg subcutaneous every 15 days.

The dosage of the medication will be administrated according to the product's approved label by SmPC (Summary of Product's Characteristics)by technical file. Administration will be accepted every 7 days, if the patient after inclusion criteria is included with intensified dose.

Study Design

Conditions

Crohn Disease

Intervention

Amgevita 40Mg Solution for Injection, HUMIRA 40Mg Solution for Injection

Status

Not yet recruiting

Source

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-24T12:49:52-0400

Clinical Trials [6027 Associated Clinical Trials listed on BioPortfolio]

Efficacy and Safety of RTH258 Versus Aflibercept - Study 2

The purpose of this study is to compare RTH258 ophthalmic solution for intravitreal (IVT) injection to aflibercept solution for IVT injection in subjects with untreated active choroidal ne...

Comparison of MENOPUR Liquid and Powder in Women Undergoing ART

Development of multiple follicles and pregnancy in ovulatory women undergoing controlled ovarian stimulation as part of an assisted reproductive technology (ART) cycle.

Sensitivity of ECG on Detection of Three Different Intravascular Applied Test Doses of Bupivacaine and Epinephrine

The purpose of this prospective randomised study is to investigate electrocardiographic alterations after intravascular injection of three different test solutions of bupivacaine and epine...

Sub-Q Versus IV Furosemide in Acute Heart Failure

This study evaluates the clinical efficacy of subcutaneously administered Furosemide Injection Solution versus intravenous administration of Furosemide Injection, USP (United States Pharma...

Efficacy of Low Dose Intravenous Proton Pump Inhibitor for Peptic Ulcer Bleeding

We prepare this study to compare the efficacy of intermittent intravenous PPI infusion (relatively low dose PPI therapy) than continous PPI infusion method. Our hypothesis is that intermit...

PubMed Articles [6066 Associated PubMed Articles listed on BioPortfolio]

Investigating the applicability of different amounts of solutions used in experiments, which performed in rat knee joints: Determining the optimal intraarticular injection volume.

The injection amount of solutions differs in wide ranges, from 20 to 200 μL in intraarticular injections experiments that was carried out with rats. The 10-fold difference between applied volumes i...

Expansion of 1 mL of Solution by Ultrasound-Guided Injection Between the Trapezius and Rhomboid Muscles: A Cadaver Study.

An ultrasound-guided interfascial injection, which targets the space between the epimysia, is often performed for myofascial neck and shoulder pain. However, the relationship between the injection vol...

Reduction of the rocuronium-induced withdrawal reflex by MR13A10A, a generic rocuronium with a novel solution: A randomized, controlled study.

Rocuronium induces venous pain and the withdrawal reflex during injection. MR13A10A, generic rocuronium with a novel solution, reduced the injection-induced withdrawal reflex in rodents. We hypothesiz...

Effect of catheter diameter and injection rate of flush solution on renal contrast-enhanced ultrasonography with perfluorobutane in dogs.

To assess effects of catheter diameter and injection rate of flush solution (saline [0.9% NaCl] solution) on renal contrast-enhanced ultrasonography (CEUS) with perfluorobutane in dogs.

Rheological Model and Transition Velocity Equation of a Polymer Solution in a Partial Pressure Tool.

In order to solve the problem of the low production degree of oil layers caused by an excessively large permeability difference between layers during polymer flooding, we propose partial pressure inje...

Medical and Biotech [MESH] Definitions

Hypertonic sodium chloride solution. A solution having an osmotic pressure greater than that of physiologic salt solution (0.9 g NaCl in 100 ml purified water).

The injection of solutions into the skin by compressed air devices so that only the solution pierces the skin.

Interruption of the conduction of impulses in peripheral nerves or nerve trunks by the injection of a local anesthetic solution. (Stedman, 26th ed)

Visualization of a vascular system after intravenous injection of a fluorescein solution. The images may be photographed or televised. It is used especially in studying the retinal and uveal vasculature.

The pressure required to prevent the passage of solvent through a semipermeable membrane that separates a pure solvent from a solution of the solvent and solute or that separates different concentrations of a solution. It is proportional to the osmolality of the solution.

More From BioPortfolio on "Loss of Response of Adalimumab Biosimilar vs Adalimumab Original, in Inflammatory Bowel Disease."

Quick Search

Relevant Topics

Antibodies
An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...

Biosimilars
Biosimilars or Follow-on biologics are terms used to describe officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. Products that ar...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...


Searches Linking to this Trial