Rheumatoid ArthritisPhase 1NCT03714022
A Study to Evaluate the Pharmacokinetics of Abatacept Converted From Drug Substance by Two Different Processes
A Phase 1 study testing Abatacept in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 2 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Abatacept
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Nov 2018to 2 Apr 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
PPD Development, LP
Austin, Texas, 78744
Qps-Mra, Llc
South Miami, Florida, 33143
About this study
Official title: A Randomized, Open-Label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of the Abatacept (BMS-188667) Drug Product Converted From Drug Substance of a New Abatacept Drug Substance Process Relative to the Current Abatacept Drug Process in Healthy Participants
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.
Read the detailed 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Abatacept
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AbataceptDrug
Participants will receive abatacept at a single dose 750 mg as IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Participants will receive abatacept at a single dose of 750 mg as IV infusion on Day 1 converted from drug substance by a new process. Receives: Drug: Abatacept |
| Treatment B | Active comparator | Participants will receive abatacept at a single dose 750 mg as IV infusion on Day 1 converted from drug substance by converted from drug substance by the current process. Receives: Drug: Abatacept |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Observed Serum Concentration (Cmax)
Maximum Observed Serum Concentration
Measured: From drug administration to 70 days following drug administration
Area Under the Curve AUC(INF)
Area under the serum concentration-time curve from time zero extrapolated to infinity
Measured: From drug administration to 70 days following drug administration
Secondary outcomes (21)
Time of Maximum Observed Serum Concentration (Tmax)
Time of maximum observed serum concentration
Measured: From drug administration to 70 days following drug administration
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
Measured: From drug administration to 70 days following drug administration
Area Under the Curve AUC(0-28)
Area under the serum concentration-time curve from time zero to 28 days after dosing
Measured: From drug administration to 70 days following drug administration
Total Body Clearance (CLT)
Total body clearance
Measured: From drug administration to 70 days following drug administration
Volume of Distribution at Steady-State (Vss)
Volume of distribution at steady-state
Measured: From drug administration to 70 days following drug administration
Terminal Phase Elimination Half-life (T-HALF)
Terminal phase elimination half-life in serum
Measured: From drug administration to 70 days following drug administration
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.
Measured: From Day 1 (Predose) to Day 71 (Study Discharge), assessed at day 1, day 29, day 57 and day 71
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
Measured: From drug administration to 56 days following drug administration
Change From Baseline in Blood Pressure
Mean Change from Baseline in systolic and diastolic blood pressure values
Measured: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Heart Rate
Mean Change from Baseline in heart rate values
Measured: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Respiration Rate
Mean Change from Baseline in respiration rate values
Measured: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Body Temperature
Mean Change from Baseline in body temperature values
Measured: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Electrocardiogram (ECG) Parameters
Mean Change from Baseline in ECG parameters, including PR interval, QRS interval, QT interval, and QTC Fridericia
Measured: From baseline (last result before start of study medication) to 70 days after start of study medication
Number of Participants Experiencing Clinically Significant Physical Examination Abnormalities
Number of participants experiencing clinically significant physical examination abnormal findings
Measured: From the pre-treatment period to 70 days after start of study medication (approximately 100 days)
Change From Baseline in Laboratory Test Results - Hematology 1
Mean Change from Baseline in laboratory test results - Hematology parameters 1
Measured: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Laboratory Test Results - Hematology 2
Mean Change from Baseline in laboratory test results - Hematology parameters 2
Measured: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Laboratory Test Results - Hematology 3
Mean Change from Baseline in laboratory test results - Hematocrit
Measured: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Laboratory Test Results - Chemistry 1
Mean Change from Baseline in laboratory test results - Chemistry parameters 1
Measured: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Laboratory Test Results - Chemistry 2
Mean Change from Baseline in laboratory test results - Chemistry parameters 2
Measured: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Laboratory Test Results - Chemistry 3
Mean Change from Baseline in laboratory test results - Chemistry parameters 3
Measured: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Laboratory Test Results -Hematology and Chemistry 4
Mean Change from Baseline in laboratory test results - hematology and chemistry parameters 4
Measured: From baseline (last result before start of study medication) to 70 days after start of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start9 Nov 2018
- Primary completion2 Apr 2019
- Study completion2 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714022
- Sponsor's protocol ID
- IM101-682
- Status last verified
- Jan 2021
- First submitted
- 18 Oct 2018
- Last updated
- 7 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Parallel-Group, Single-dose, Biocomparability Study of the Pharmacokinetics of the Abatacept (BMS-188667) Drug Product Converted From Drug Substance of a New Abatacept Drug Substance Process Relative to the Current Abatacept Drug Process in Healthy Participants
- ClinicalTrials.gov ID
- NCT03714022
- Acronym / sponsor ID
- IM101-682
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2018 (actual)
- Primary completion
- 2 Apr 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Posted 7 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: AbataceptParticipants will receive abatacept at a single dose of 750 mg as IV infusion on Day 1 converted from drug substance by a new process. |
| Treatment B | Active comparator | Drug: AbataceptParticipants will receive abatacept at a single dose 750 mg as IV infusion on Day 1 converted from drug substance by converted from drug substance by the current process. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AbataceptParticipants will receive abatacept at a single dose 750 mg as IV infusion. | Drug | Treatment A, Treatment B |
Primary outcome
Maximum Observed Serum Concentration (Cmax)
Time frame: From drug administration to 70 days following drug administration
Maximum Observed Serum Concentration
Area Under the Curve AUC(INF)
Time frame: From drug administration to 70 days following drug administration
Area under the serum concentration-time curve from time zero extrapolated to infinity
21 secondary outcomes
Time of Maximum Observed Serum Concentration (Tmax)
Time frame: From drug administration to 70 days following drug administration
Area Under the Curve AUC(0-T)
Time frame: From drug administration to 70 days following drug administration
Area Under the Curve AUC(0-28)
Time frame: From drug administration to 70 days following drug administration
Total Body Clearance (CLT)
Time frame: From drug administration to 70 days following drug administration
Volume of Distribution at Steady-State (Vss)
Time frame: From drug administration to 70 days following drug administration
Terminal Phase Elimination Half-life (T-HALF)
Time frame: From drug administration to 70 days following drug administration
Number of Participants Experiencing Positive Immunogenicity Response to Abatacept
Time frame: From Day 1 (Predose) to Day 71 (Study Discharge), assessed at day 1, day 29, day 57 and day 71
Number of Participants Experiencing Adverse Events
Time frame: From drug administration to 56 days following drug administration
Change From Baseline in Blood Pressure
Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Heart Rate
Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Respiration Rate
Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Body Temperature
Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication
Number of Participants Experiencing Clinically Significant Physical Examination Abnormalities
Time frame: From the pre-treatment period to 70 days after start of study medication (approximately 100 days)
Change From Baseline in Laboratory Test Results - Hematology 1
Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Laboratory Test Results - Hematology 2
Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Laboratory Test Results - Hematology 3
Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Laboratory Test Results - Chemistry 1
Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Laboratory Test Results - Chemistry 2
Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Laboratory Test Results - Chemistry 3
Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication
Change From Baseline in Laboratory Test Results -Hematology and Chemistry 4
Time frame: From baseline (last result before start of study medication) to 70 days after start of study medication
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Abatacept in people with Rheumatoid Arthritis, run by Bristol-Myers Squibb at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Observed Serum Concentration (Cmax) (time frame: From drug administration to 70 days following drug administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2021; AzTrials last refreshed its copy on 26 Oct 2026.