NCT05172817View on ClinicalTrials.gov

Study to Compare PK & Safety of Advixa With Humira in Healthy, Adult Subject Followed by Efficacy & Safety Study in RA Patients

PHASE2/PHASE3UnknownINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

June 2, 2021

Primary Completion Date

November 30, 2021

Study Completion Date

October 30, 2022

Conditions
PharmacokineticsSafetyEfficacyRheumatoid Arthritis
Interventions
DRUG

Advixa (Adalimumab)

Injection Advixa(Adalimumab) 40 mg/ 0.4 ml will be administered subcutaneously to the participants by trained medical personnel. Single dose for phase 2 and biweekly for 3 months for phase 3.

Trial Locations (1)

1212

RECRUITING

ideSHi, Dhaka

Sponsors
All Listed Sponsors
collaborator

Universal Medical College Hospital, Bangladesh

UNKNOWN

collaborator

Green Life Center for Rheumatic Care & Research, Bangladesh

UNKNOWN

collaborator

Incepta Pharmaceuticals Ltd, Bangladesh

UNKNOWN

lead

Institute for Developing Science and Health Initiatives, Bangladesh

OTHER

NCT05172817 - Study to Compare PK & Safety of Advixa With Humira in Healthy, Adult Subject Followed by Efficacy & Safety Study in RA Patients | Biotech Hunter | Biotech Hunter