Study to Demonstrate Equivalent Efficacy & to Compare Safety of Biosimilar

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

See also
	Status	Clinical Trial	Phase
	Completed	`NCT01646567` - SHP-141C in Plaque Type Psoriasis	Phase 1
	Completed	`NCT02660580` - MSB11022 in Moderate to Severe Chronic Plaque Psoriasis	Phase 3

See also

Status

Clinical Trial

Phase

Completed

NCT01646567 - SHP-141C in Plaque Type Psoriasis

Phase 1

Completed

NCT02660580 - MSB11022 in Moderate to Severe Chronic Plaque Psoriasis

Phase 3

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT02016105
Study type	Interventional
Source	Sandoz
Contact
Status	Completed
Phase	Phase 3
Start date	December 2013
Completion date	February 2016

Study to Demonstrate Equivalent Efficacy and to Compare Safety of Biosimilar Adalimumab (GP2017) and Humira — ADACCESS

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms