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

Summary

Adalimumab is a recombinant monoclonal antibody (IgG1 subclass) against human TNF-α (Tumor Necrosis Factor-alpha). It is an immunosuppressive medication predominantly used to treat rheumatoid arthritis autoimmune disease. It is also used for the treatment of psoriatic arthritis, ankylosing spondylitis, and Crohn's disease etc. Adalimumab binds specifically to TNF-α and blocks its general cytokine effects, thereby reducing TNF-induced inflammation and halting tissue destruction. Adalimumab was approved for medical use in the United States in 2002. It is on the World Health Organization's List of Essential Medicines. It is available as a biosimilar medication. In 2017, it was the 169th most commonly prescribed medication in the United States, with more than three million prescriptions. Adalimumab is an expensive product which is indicated in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, etc. Each patient will be provided the study drug free of cost in this study which will benefit them immensely.

The advent of therapeutic monoclonal antibodies has given a major boost to the treatment of individuals suffering from autoimmune disorders, including rheumatoid arthritis. Adalimumab is one such therapeutic monoclonal antibody used for treatment of rheumatoid arthritis marketed with brand name Humira by Abbvie Ltd. (USA) was the only adalimumab biosimilar available for patients in Bangladesh until recently. Incepta Pharmaceuticals Ltd. Bangladesh has introduced Bangladesh's first locally manufactured adalimumab biosimilar Advixa that is available at a fraction of Humira's cost. This study aims to evaluate the pharmacokinetics, safety and efficacy of the Adalimumab biosimilar (Advixa) in comparison to Adalimumab (Humira) as reference. The biosimilar Advixa being a local product will a cost-effective alternative to imported drugs currently available in the market.

Objectives of the Protocol

General objectives-

1. To assess the Pharmacokinetic between Test Product (A): Adalimumab (Advixa) 40 mg/ 0.4 ml of Incepta Pharmaceuticals Ltd of Bangladesh and the corresponding Reference Product

(B): Humira 40 mg/ 0.4ml of Abbvie Ltd in normal, healthy, adult, human subjects in a Parallel group study.
2. To evaluate the safety between two products.
3. To assess efficacy, tolerability and safety of biosimilar adalimumab (Advixa, Incepta) in compared with reference adalimumab (Humira, AbbVie) in patients with moderate to severe rheumatoid arthritis (RA).

Specific objectives-

1. Pharmacokinetic (PK) Parameters: For Cmax and AUC0-t the 90% confidence interval for the ratio of the test and reference products should be contained within the acceptance interval of 80.00-125.00%.
2. Safety assessment: Evaluation and comparison between references vs. test drug in terms of safety end point.
3. Efficacy assessment: The primary endpoints will be -

1. Proportion of patients with an ACR20 response in both the treatment groups at week 12.
2. Evaluation and comparison of safety between references vs. test drug.

The secondary endpoints will be -

1. Change in Disease Activity Score of 28 joints - CRP (DAS28-CRP),
2. Proportion of patient with an ACR50 response and
3. Proportion of patients with an ACR70 response in both the treatment groups at week 12.

Conditions

• Pharmacokinetics
• Safety
• Efficacy
• Rheumatoid 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.

Sponsors & Collaborators

• Universal Medical College Hospital, Bangladesh

  collaborator UNKNOWN

• Green Life Center for Rheumatic Care & Research, Bangladesh

  collaborator UNKNOWN

• Incepta Pharmaceuticals Ltd, Bangladesh

  collaborator UNKNOWN

• Institute for Developing Science and Health Initiatives, Bangladesh

  lead OTHER

Principal Investigators

• Zannat Kawser, M.Phil. · institute for developing Science and Health initiatives

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-06-02

Primary Completion

2021-11-30

Completion

2022-10-30

Countries

• Bangladesh

Study Locations