Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03714022
Other study ID # IM101-682
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date November 9, 2018
Est. completion date April 2, 2019

Study information

Verified date January 2021
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main objective of this study is to compare the pharmacokinetics (PK) of the abatacept drug product converted from drug substance by a new drug substance process (Treatment A) relative to the current drug substance process (Treatment B) following a single dose (750 mg) intravenous (IV) infusion in healthy participants.


Description:

Participants will be admitted to the clinical facility the day prior to dosing (Day -1) and will be confined until at least 24 hours post-dose. On Day 1, eligible participants will be randomized in a 1:1 ratio to either Treatment A or Treatment B. The randomization will be stratified by weight categories: >= 60 to < 70 kg, >= 70 to < 80 kg, >= 80 to < 90 kg, and >= 90 to <= 100 kg.


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date April 2, 2019
Est. primary completion date April 2, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - Body weight will be between 60 and 100 kg, inclusive. - Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within 24 hours prior to the start of study treatment. - Women must not be breastfeeding. - WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with abatacept plus 5 half-lives of abatacept (85 days) plus 30 days (duration of ovulatory cycle) for a total of 115 days post-treatment completion. - Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with abatacept plus 5 half-lives of abatacept (85 days) plus the duration of spermatogenesis (90 days) for a total of 175 days after the last dose of study treatment. In addition, male participants must be willing to refrain from sperm donation during this time. Exclusion Criteria: - Participants who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Participants who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations. - Participants with a history of herpes zoster. - Donation of blood to a blood bank or in a clinical study (except a screening visit or follow-up visit) within 4 weeks of study treatment administration (within 2 weeks of study treatment administration for plasma only). - Blood transfusion within 4 weeks of study treatment administration. - Recent (within 6 months of study treatment administration) history of smoking or current smokers. This includes participants using electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges, or nicotine gum. - History of allergy to abatacept or related compounds.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Abatacept
Participants will receive abatacept at a single dose 750 mg as IV infusion.

Locations

Country Name City State
United States PPD Development, LP Austin Texas
United States Qps-Mra, Llc South Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum Observed Serum Concentration (Cmax) Maximum Observed Serum Concentration From drug administration to 70 days following drug administration
Primary Area Under the Curve AUC(INF) Area under the serum concentration-time curve from time zero extrapolated to infinity From drug administration to 70 days following drug administration
Secondary Time of Maximum Observed Serum Concentration (Tmax) Time of maximum observed serum concentration From drug administration to 70 days following drug administration
Secondary Area Under the Curve AUC(0-T) Area under the serum concentration-time curve from zero to the last time of the last quantifiable concentration From drug administration to 70 days following drug administration
Secondary Area Under the Curve AUC(0-28) Area under the serum concentration-time curve from time zero to 28 days after dosing From drug administration to 70 days following drug administration
Secondary Total Body Clearance (CLT) Total body clearance From drug administration to 70 days following drug administration
Secondary Volume of Distribution at Steady-State (Vss) Volume of distribution at steady-state From drug administration to 70 days following drug administration
Secondary Terminal Phase Elimination Half-life (T-HALF) Terminal phase elimination half-life in serum From drug administration to 70 days following drug administration
Secondary Number of Participants Experiencing Positive Immunogenicity Response to Abatacept Positive immunogenicity response to Abatacept was defined if one of the following criteria was met:
missing baseline immunogenicity measurement and a positive, post-baseline, laboratory-reported immunogenicity response;
a negative laboratory-reported baseline immunogenicity response and a positive, post-baseline, laboratory-reported response;
a positive, laboratory-reported, baseline immunogenicity response and a positive, post-baseline, laboratory-reported immunogenicity response with a titer value greater than the baseline titer value.
From Day 1 (Predose) to Day 71 (Study Discharge), assessed at day 1, day 29, day 57 and day 71
Secondary Number of Participants Experiencing Adverse Events Number of participants experiencing different types of Adverse Events (AEs). Peri-infusional AEs: occurring during the 30 minute study drug infusion period Post-infusional AEs: occurring within 24 hours post drug infusion From drug administration to 56 days following drug administration
Secondary Change From Baseline in Blood Pressure Mean Change from Baseline in systolic and diastolic blood pressure values From baseline (last result before start of study medication) to 70 days after start of study medication
Secondary Change From Baseline in Heart Rate Mean Change from Baseline in heart rate values From baseline (last result before start of study medication) to 70 days after start of study medication
Secondary Change From Baseline in Respiration Rate Mean Change from Baseline in respiration rate values From baseline (last result before start of study medication) to 70 days after start of study medication
Secondary Change From Baseline in Body Temperature Mean Change from Baseline in body temperature values From baseline (last result before start of study medication) to 70 days after start of study medication
Secondary Change From Baseline in Electrocardiogram (ECG) Parameters Mean Change from Baseline in ECG parameters, including PR interval, QRS interval, QT interval, and QTC Fridericia From baseline (last result before start of study medication) to 70 days after start of study medication
Secondary Number of Participants Experiencing Clinically Significant Physical Examination Abnormalities Number of participants experiencing clinically significant physical examination abnormal findings From the pre-treatment period to 70 days after start of study medication (approximately 100 days)
Secondary Change From Baseline in Laboratory Test Results - Hematology 1 Mean Change from Baseline in laboratory test results - Hematology parameters 1 From baseline (last result before start of study medication) to 70 days after start of study medication
Secondary Change From Baseline in Laboratory Test Results - Hematology 2 Mean Change from Baseline in laboratory test results - Hematology parameters 2 From baseline (last result before start of study medication) to 70 days after start of study medication
Secondary Change From Baseline in Laboratory Test Results - Hematology 3 Mean Change from Baseline in laboratory test results - Hematocrit From baseline (last result before start of study medication) to 70 days after start of study medication
Secondary Change From Baseline in Laboratory Test Results - Chemistry 1 Mean Change from Baseline in laboratory test results - Chemistry parameters 1 From baseline (last result before start of study medication) to 70 days after start of study medication
Secondary Change From Baseline in Laboratory Test Results - Chemistry 2 Mean Change from Baseline in laboratory test results - Chemistry parameters 2 From baseline (last result before start of study medication) to 70 days after start of study medication
Secondary Change From Baseline in Laboratory Test Results - Chemistry 3 Mean Change from Baseline in laboratory test results - Chemistry parameters 3 From baseline (last result before start of study medication) to 70 days after start of study medication
Secondary Change From Baseline in Laboratory Test Results -Hematology and Chemistry 4 Mean Change from Baseline in laboratory test results - hematology and chemistry parameters 4 From baseline (last result before start of study medication) to 70 days after start of study medication
See also
  Status Clinical Trial Phase
Completed NCT04226131 - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics N/A
Completed NCT04171414 - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis Phase 3
Completed NCT02833350 - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA) Phase 2
Completed NCT04255134 - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN) Phase 4
Recruiting NCT05615246 - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Completed NCT03248518 - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Recruiting NCT06005220 - SBD121, a Synbiotic Medical Food for RA Management N/A
Recruiting NCT05451615 - Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis Phase 3
Completed NCT05054920 - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis N/A
Completed NCT02037737 - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting N/A
Recruiting NCT04079374 - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel Phase 3
Completed NCT02504268 - Effects of Abatacept in Patients With Early Rheumatoid Arthritis Phase 3
Recruiting NCT05496855 - Remote Care in People With Rheumatoid Arthritis N/A
Completed NCT05051943 - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting NCT06103773 - A Study of Single and Multiple Oral Doses of TollB-001 Phase 1
Recruiting NCT06031415 - Study of GS-0272 in Participants With Rheumatoid Arthritis Phase 1
Completed NCT05999266 - The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Recruiting NCT05302934 - Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Recruiting NCT04169100 - Novel Form of Acquired Long QT Syndrome Phase 4