Study to Characterize the Pharmacokinetics of a Single Dose of SC Abatacept 125 mg Using the BD Autoinjector or the Prefilled Syringe

NCT01890473 | Completed Phase 1 Results

• 1 other identifier: IM101-366
• Study Type: interventional
• Target: 356
• Locations: 5 countries
• Sites: 25

Brief Summary

The primary purpose of the protocol is to describe the pharmacokinetics of a single dose of Abatacept 125 mg in Rheumatoid Arthritis patients delivered via the autoinjector device or the approved prefilled syringe.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (3)

• Adjusted Geometric Mean of Maximum Observed Serum Concentration (Cmax) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population

  Serum concentrations of abatacept were analyzed using a validated enzyme-linked immunosorbent assay (ELISA). Cmax was measured in micrograms per milliliter (μg/mL). Blood samples for pharmacokinetic (PK) parameters were collected at Day 1 pre-dose at 0 hour (h), 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC.

  Day 1 to Day 71

• Adjusted Geometric Mean of Area Under the Serum Concentration-time Curve (AUC) From Zero to the Last Time of the Last Quantifiable Concentration (0-T) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population

  Serum concentrations of abatacept were analyzed using ELISA. AUC (0-T) was measured in μg\*h/mL. Blood samples were collected at Day 1 pre-dose at 0 h, 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC.

  Day 1 to Day 71

• Adjusted Geometric Mean of Area Under the Serum Concentration-time Curve From Time Zero to Extrapolated to Infinity, AUC (INF), of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population

  Serum concentrations of abatacept were analyzed using ELISA. Blood samples were collected at Day 1 pre-dose at 0 hour (h), 1, 2, and 8 h post dose, and on subsequent Days, 2 (24 h post dose), 3 (48 h), 5 (96 h), 8 (168 h), 15 (336 h), 29 (672 h) , 43 (1008 h), 57 (1344 h) and 71 (1680 h) following the single administration of abatacept SC. AUC (INF) was measured in μg\*h/mL

  Day 1 to Day 71

Secondary Outcomes (8)

• Median of Time to Reach Cmax in Serum (Tmax) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population

  Day 1 to Day 71

• Mean of Terminal Phase Elimination Half-life in Serum (T-HALF) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population

  Day 1 to Day 71

• Geometric Mean of Total Body Clearance (CL/F) of a Single Dose of SC Abatacept - PK-Evaluable Analysis Population

  Day 1 to Day 71

• Geometric Mean of Volume of Distribution (V/F) of a Single Dose of Subcutaneous (SC) Abatacept - PK-Evaluable Analysis Population

  Day 1 to Day 71

• Number of Participants Who Had Serious Adverse Events (SAEs), Adverse Events (AEs) That Led to Discontinuation, or Who Died

  Day 1 to 76 days post single dose

Study Arms (2)

Arm 1: Abatacept (autoinjector)

EXPERIMENTAL

Abatacept 125 mg/syringe subcutaneously through autoinjector, one dose in 71 days

Drug: Abatacept

Arm 2: Abatacept (prefilled syringe)

EXPERIMENTAL

Abatacept 125 mg/syringe subcutaneously with prefilled syringe, one dose in 71 days

Drug: Abatacept

Interventions

Abatacept DRUG

Also known as: Orencia, BMS-188667

Arm 1: Abatacept (autoinjector); Arm 2: Abatacept (prefilled syringe)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects ≥18 years of age
• Diagnosis of Rheumatoid Arthritis confirmed by participant's physician
• Disease activity under control

You may not qualify if:

• Change in disease-modifying antirheumatic drug (DMARD) therapy within 3 months of enrollment
• Exposure to investigational drug within 4 weeks or 5 half lives whichever is longer
• Current or prior use of Rituximab ≤6 months
• Current or prior use of the following within 4 weeks or 5 half lives whichever is longer: biologic DMARDS, Tofacitinib, Cyclophosphamide, Mycophenolate Mofetil \& d-Penicillamine

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (25)

Rheumatology Associates Of North Alabama, P.C.

Huntsville, Alabama, 35801, United States

Location

Immunoe Int'L Research Ctrs

Centennial, Colorado, 80112, United States

Location

Covance Cru Inc

Daytona Beach, Florida, 32117, United States

Location

Heartland Research Associates, Llc

Wichita, Kansas, 67207, United States

Location

Clinical Pharmacology Study Group

Worcester, Massachusetts, 01605, United States

Location

Physician Research Collaboration, Llc

Lincoln, Nebraska, 68516, United States

Location

Djl Research, Pllc

Charlotte, North Carolina, 28210, United States

Location

Wake Research Associates

Raleigh, North Carolina, 27612, United States

Location

Pmg Research Of Salisbury

Salisbury, North Carolina, 28144, United States

Location

Pmg Research Of Wilmington Llc

Wilmington, North Carolina, 28401, United States

Location

Community Research

Cincinnati, Ohio, 45255, United States

Location

Altoona Center For Clinical Research

Duncansville, Pennsylvania, 16635, United States

Location

Covance Clinical Research Unit Inc.

Dallas, Texas, 75247, United States

Location

Local Institution

San Fernando, Buenos Aires, 1646, Argentina

Location

Local Institution

Córdoba, Córdoba Province, 5000, Argentina

Location

Local Institution

Córdoba, Córdoba Province, 5016, Argentina

Location

Local Institution

Rosario, Santa Fe Province, 2000, Argentina

Location

Local Institution

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Local Institution

Yucatán, Yucatán, 97000, Mexico

Location

Local Institution

Lima, Lima Province, 33, Peru

Location

Local Institution

Lima, Lima Province, LIMA 01, Peru

Location

Local Institution

Port Elizabeth, Eastern Cape, 6001, South Africa

Location

Local Institution

Pretoria, Gauteng, 0122, South Africa

Location

Local Institution

Pretoria, Gauteng, 0184, South Africa

Location

Local Institution

George, Western Cape, 6529, South Africa

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2013
• First Posted: July 1, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 26, 2015
• Results First Posted: November 26, 2015

Record last verified: 2015-10

Locations

ZA (4); AR (5); PE (2); US (13); ME (1)