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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 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
2%
Headache
1%
Anaemia
1%
Pyrexia
100%
80%
60%
40%
20%
0%
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

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.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Dr. Reddy's Laboratories LimitedLead Sponsor
235 Previous Clinical Trials
47,157 Total Patients Enrolled
3 Trials studying Rheumatoid Arthritis
716 Patients Enrolled for Rheumatoid Arthritis
Naveen Reddy, MDStudy ChairDr. Reddy's Laboratories
~165 spots leftby Oct 2025
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