Study to Assess Changes in the Immune Profile in Adults With Early Rheumatoid Arthritis

A Randomized, Head-to-Head, Single-Blinded Study to Assess Changes in the Immune Profile in Response to Treatment With Subcutaneous Abatacept in Combination With Methotrexate Versus Subcutaneous Adalimumab in Combination With Methotrexate in Adults With Early Rheumatoid Arthritis Who Are Naive to Biologic Disease-Modifying Antirheumatic Drugs

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02557100

Enrollment

Registered

2015-09-23

Start date

2015-11-19

Completion date

2019-03-28

Last updated

2020-09-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Brief summary

The purpose of this study is to examine changes in immune cells and proteins in response to treatment with two approved therapies for Rheumatoid arthritis (RA), abatacept versus adalimumab, both given in combination with methotrexate.

Interventions

DRUGAbatacept

DRUGAdalimumab

DRUGMethotrexate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: * Symptoms of RA for no more than 12 months prior to enrollment * Meet American College of Rheumatology/European League against Rheumatism (ACR/EULAR) 2010 criteria for classification of RA * Treated with Methotrexate (MTX) for at least 12 weeks prior to randomization with a stable oral dose for at least 4 weeks, Subjects must randomize on the maximum tolerated dose of oral methotrexate (minimum of 15 mg and maximum of 25 mg per week), dose of MTX \< 15 mg/week but ≥ 7.5 mg/week is permitted if subjects are intolerant to higher doses * At least 3 tender & 3 swollen joints * Anti-cyclic citrullinated peptide (CCP) \> 3X the upper limit of normal and positive rheumatoid factor

Exclusion criteria

* History of other autoimmune diseases (eg, psoriasis, systemic lupus, erythematosus, etc) * Prior use of non-biologic therapy other than methotrexate * Prior use of biologic and targeted synthetic disease-modifying anti-rheumatic drugs (DMARD) therapy * Subjects with chronic or recent acute serious infection Other protocol defined inclusion/

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Adverse Events (AEs)	up to 85 days post last dose, approximately 40 weeks	Percentage of participants who experienced an AE
Percentage of Participants With an Serious Adverse Events (SAEs)	up to 85 days post last dose, approximately 40 weeks	Percentage of participants who experienced an SAEs
Percentage of Participants With Adverse Events Leading to Discontinuation (AEsDc)	up to 85 days post last dose, approximately 40 weeks	Percentage of participants who experienced an (AEsDc)
Percentage of Serious Adverse Events Leading to Discontinuation (SAEsDc)	up to 85 days post last dose, approximately 40 weeks	Percentage of participants who experienced an (SAEsDc)
Percentage of Drug Related Adverse Events (DRAEs)	up to 85 days post last dose, approximately 40 weeks	Percentage of participants who experienced an DRAEs
Percentage of Drug Related Serious Adverse Events (DRSAEs)	up to 85 days post last dose, approximately 40 weeks	Percentage of participants who experienced an DRSAEs
Number of Deaths	up to 85 days post last dose, approximately 40 weeks	Number of participants who experienced Death

Countries

Canada, Mexico, United States

Participant flow

Pre-assignment details

80 participants randomized and treated.

Participants by arm

Arm	Count
Treatment A Abatacept Single Blind Treatment Period	40
Treatment B Adalimumab Single Blind Treatment Period	40
Treatment C Cumulative Abatacept Period	0
Total	80

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Cumulative Abatacept Period	Lost to Follow-up	0	0	2
Cumulative Abatacept Period	Other Reasons	0	0	1
Cumulative Abatacept Period	Request to Discontinue	0	0	1
Single Blind Treatment Period	Adverse Event	0	1	0
Single Blind Treatment Period	Death	0	1	0
Single Blind Treatment Period	Lost to Follow-up	0	1	0
Single Blind Treatment Period	Request to Discontinue	0	1	0
Transition to Open Label	Entered Cumulative Abatacept Period	40	36	0

Baseline characteristics

Characteristic	Treatment B	Total	Treatment A
Age, Continuous	44.7 Years STANDARD_DEVIATION 16.3	46.0 Years STANDARD_DEVIATION 14.35	47.2 Years STANDARD_DEVIATION 12.16
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants	10 Participants	4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants	30 Participants	16 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	20 Participants	40 Participants	20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Asian	2 Participants	2 Participants	0 Participants
Race (NIH/OMB) Black or African American	1 Participants	5 Participants	4 Participants
Race (NIH/OMB) More than one race	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants	0 Participants	0 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants	1 Participants	0 Participants
Race (NIH/OMB) White	36 Participants	72 Participants	36 Participants
Sex: Female, Male Female	31 Participants	60 Participants	29 Participants
Sex: Female, Male Male	9 Participants	20 Participants	11 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 40	1 / 40	0 / 76
other Total, other adverse events	21 / 40	28 / 40	19 / 76
serious Total, serious adverse events	1 / 40	2 / 40	4 / 76