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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

Study Summary

This trial is testing 3 different abatacept products to compare safety, effectiveness, and how they are absorbed by the body.

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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

%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)

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

Find a Location

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

234 Previous Clinical Trials

22,899 Total Patients Enrolled

3 Trials studying Rheumatoid Arthritis

716 Patients Enrolled for Rheumatoid Arthritis

Naveen Reddy, MDStudy ChairDr. Reddy's Laboratories

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has DRL_AB been given the green light from the FDA?

"Our team at Power assessed DRL_AB's safety on a scale of 1 to 3. Given it is in Phase 1, where limited data supports its efficacy and safety, we gave the drug a score of 1."

Answered by AI

Does the experimental protocol allow for octogenarians to participate?

"Aspiring participants of this clinical trial must be under the age of 50 and above 18 years old."

Answered by AI

Who would be the ideal candidates for this research trial?

"Eligible applicants of this medical trial should have a diagnosis of rheumatoid arthritis and be aged between 18 - 50 years old. In total, 330 individuals are required to take part in the research project."

Answered by AI

What objectives are investigators attempting to accomplish through this medical experiment?

"This medical trial will measure a variety of outcomes over a 85-day period. Most notably, the single dose pharmacokinetic parameter for Maximum Observed Serum Concentration (Cmax), as well as CL/f Pharmacokinetic parameters and Positive Abatacept-induced Immunogenicity Response incidence titer and neutralizing capacity. In terms of safety assessments, Change From Baseline in Systolic and diastolic Blood Pressure will be observed closely."

Answered by AI

What is the participant enrollment for this trial?

"The sponsor has specified that 330 suitable participants are required to initiate the trial. This will be achieved through two major sites, ICON Early Phase Services, LLC in San Antonio and another located within Salt Lake City."

Answered by AI

Is recruitment for this investigation still open?

"Data available on clinicaltrials.gov attests that this trial is actively looking for participants to join the experiment. First posted on October 3rd 2023, it has been most recently updated as of November 8th 2023."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparative Pharmacokinetic Study of Three Abatacept Products in Male Normal Healthy Volunteers by the Subcutaneous Route

2023. "Comparative Pharmacokinetic Study of Three Abatacept Products in Male Normal Healthy Volunteers by the Subcutaneous Route". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06126042.

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