What side effects are associated with this type of intervention?

Common treatments for Rheumatoid Arthritis (RA) similar to Abatacept include biologic agents such as TNF inhibitors (e.g., etanercept, adalimumab) and other DMARDs like methotrexate. Known side effects of these treatments can include increased risk of infections, injection site reactions, and potential liver toxicity. TNF inhibitors may also cause allergic reactions, heart failure, and demyelinating diseases. Methotrexate can lead to gastrointestinal issues, liver damage, and bone marrow suppression. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

Abatacept, a selective T-cell co-stimulation modulator, is FDA-approved for the treatment of Rheumatoid Arthritis (RA). Other similar biologic agents approved for RA include Rituximab, which targets CD20-positive B cells, and Tocilizumab, an IL-6 receptor inhibitor. Additionally, TNF inhibitors such as Infliximab, Etanercept, and Adalimumab have been widely used and approved for RA treatment. These biologic agents work by targeting specific components of the immune system to reduce inflammation and halt disease progression.

What other types of research exist?

Promising novel alternatives to Abatacept for Rheumatoid Arthritis patients in 2024 include Janus Kinase (JAK) inhibitors such as Upadacitinib and Tofacitinib, which have shown efficacy in clinical trials. Additionally, biologics like Secukinumab (an IL-17A inhibitor) and newer IL-6 inhibitors may also be considered as effective options.

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Monoclonal Antibodies

Abatacept Comparison for Rheumatoid Arthritis

Phase 1

Recruiting

Research Sponsored by Dr. Reddy's Laboratories Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy Male volunteers, 18 to 50 years of age at the time of signing informed consent

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1hour prior to the drug administration, at hours 1,4,12,24,36,48, 60,72,84,96,108,120,132,144,156,168,216 post study drug administration & on days 15, 22, 29, 36, 43, 50, 57,71,85 (end of study)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests three versions of abatacept in healthy male volunteers to ensure safety and effectiveness. Abatacept helps calm down an overactive immune system to reduce inflammation and has been shown to be effective and safe in treating rheumatoid arthritis and psoriatic arthritis.

Who is the study for?

This trial is for healthy male volunteers aged 18 to 50, with a BMI of 18.5-30 and weight between 60-100 kg. They should be in good health as confirmed by medical exams and willing to use effective contraception. Participants must consent to follow study procedures for up to 16 weeks.

What is being tested?

The study is testing three different abatacept products (DRL_AB, RP, RMP) given by injection under the skin in men who do not have any health issues. It's designed to compare how the body processes these drugs, their safety, and potential immune responses.

What are the potential side effects?

While specific side effects are not listed here, common reactions may include irritation at the injection site, allergic reactions or rashes; general side effects can range from headaches and nausea to more serious immune system responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a healthy male aged 18 to 50.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1hour prior to the drug administration, at hours 1,4,12,24,36,48, 60,72,84,96,108,120,132,144,156,168,216 post study drug administration & on days 15, 22, 29, 36, 43, 50, 57,71,85 (end of study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1hour prior to the drug administration, at hours 1,4,12,24,36,48, 60,72,84,96,108,120,132,144,156,168,216 post study drug administration & on days 15, 22, 29, 36, 43, 50, 57,71,85 (end of study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1hour prior to the drug administration, at hours 1,4,12,24,36,48, 60,72,84,96,108,120,132,144,156,168,216 post study drug administration & on days 15, 22, 29, 36, 43, 50, 57,71,85 (end of study) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Single-dose pharmacokinetic parameter Area under the serum concentration-time curve from time zero extrapolated to infinity [AUC(INF)] will be derived from serum concentration versus time data [Time frame over 85 days as mentioned]

Single-dose pharmacokinetic parameter Maximum observed serum concentration (Cmax) will be derived from serum concentration versus time data [Time frame over 85 days]

Secondary study objectives

%AUCext

Area under the serum concentration-time curve from zero to the last time of the last quantifiable concentration will be derived from serum concentration versus time data

CL/f

+17 more

Side effects data

From 2019 Phase 3 trial • 1550 Patients • NCT04051710

Headache

Anaemia

Pyrexia

100%

80%

60%

40%

20%

Study treatment Arm

Group I (Test)

Group II (Reference)

Group III (Placebo)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: DRL_ABExperimental Treatment1 Intervention

Drug: Abatacept Prefilled Syringe Each pre-filled syringe contains 125 mg of abatacept in 1 mL Other Name: Dr. Reddy's Abatacept

Group II: RPActive Control1 Intervention

Drug: Abatacept Prefilled Syringe Each pre-filled syringe contains 125 mg of abatacept in 1 mL Other Names: Orencia

Group III: RMPActive Control1 Intervention

Drug: Abatacept Prefilled Syringe Each pre-filled syringe contains 125 mg of abatacept in 1 mL Other Names: Orencia

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Test Product

2022

Completed Phase 3

~3060

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Abatacept, a selective T-cell co-stimulation modulator, works by inhibiting T-cell activation, thereby reducing inflammation and joint damage in Rheumatoid Arthritis (RA). This is crucial as T-cells play a significant role in the autoimmune response of RA. Other common treatments include TNF inhibitors, which block the inflammatory cytokine TNF, and methotrexate, which reduces immune system activity by inhibiting folic acid metabolism. Understanding these mechanisms helps in tailoring effective treatment plans to manage symptoms and slow disease progression for RA patients.