NCT02504268|CompletedPhase 3Results

Effects of Abatacept in Patients With Early Rheumatoid Arthritis

AVERT-2

A Phase 3B, Randomized, Double-Blind Clinical Trial to Evaluate the Efficacy and Safety of Abatacept SC in Combination With Methotrexate Compared to Methotrexate Monotherapy in Achieving Clinical Remission in Adults With Early Rheumatoid Arthritis Who Are Methotrexate Naive

Bristol-Myers Squibb ClinicalTrials.gov

Compare

2 other identifiers

IM101-5502015-001275-50

Study Type

interventional

Target

994

Locations

30 countries

Sites

200

Timeline

RegisteredJul 2015

StartedSep 2015

CompletionMar 2020

Brief Summary

The purpose of this study is to determine if abatacept is effective in the treatment of early rheumatoid arthritis.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

994

participants targeted

Target at P75+ for phase_3 rheumatoid-arthritis

Timeline

Completed

Started Sep 2015

Longer than P75 for phase_3 rheumatoid-arthritis

Geographic Reach

30 countries

200 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.5 years study duration

First Submitted

Initial submission to the registry

July 20, 2015

Completed

1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2015

Completed

1 month until next milestone

Study Start

First participant enrolled

September 3, 2015

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 16, 2017

Completed

2.2 years until next milestone

Results Posted

Study results publicly available

April 8, 2019

Completed

12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2020

Completed

Last Updated

June 28, 2021

Status Verified

June 1, 2021

Enrollment Period

1.4 years

First QC Date

July 20, 2015

Results QC Date

January 16, 2019

Last Update Submit

June 25, 2021

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

Percentage of Participants in Simple Disease Activity Index (SDAI) Remission at Week 24
Simple Disease Activity Index (SDAI) is calculated using the following formula: TJC + SJC + PGA + MDGA + CRP (TJC = number of painful joints from 28 joints, SJC = number of swollen joints from 28 joints, PGA = patient global assessment on a visual analog scale 0-10 cm, MDGA = physician global assessment on a visual analog scale 0-10 cm, and CRP = c-reactive protein in mg/dL) SDAI Remission is defined as SDAI \<= 3.3. Using a logistic regression model that includes treatment arm, randomization stratification factor, and baseline SDAI as continuous variable and point estimate of adjusted ORs, corresponding 95% CI and p-value was provided. SDAI total score range: 0 to 86. SDAI \<= 3.3 indicates disease remission and SDAI \>26 = high disease activity.
Week 24

Secondary Outcomes (4)

Percentage of Participants in Disease Activity Score (DAS)28 - C-reactive Protein (CRP) Remission at Week 24
Week 24
Percentage of Participants in SDAI Remission at Week 52
Week 52
Mean Change From Baseline in Radiographic Progression of Joint Damage as Measured by Modified Sharp/Van Der Heijide Total Sharp Scores (TSS) at Week 52
Week 52
Percentage of Participants in Boolean Remission at Week 52
Week 52

Study Arms (4)

Combination Therapy: Abatacept + Methotrexate

EXPERIMENTAL

Abatacept 125 mg subcutaneous injection once per week + Methotrexate at least 15mg per week tablet or capsule orally once per week

Drug: AbataceptDrug: Methotrexate

Methotrexate treatment

ACTIVE COMPARATOR

Methotrexate at least 15mg per week tablet or capsule orally

Drug: Methotrexate

Abatacept Placebo

PLACEBO COMPARATOR

Placebo for Abatacept subcutaneous injection once per week

Other: Abatacept Placebo

Methotrexate Placebo

PLACEBO COMPARATOR

Placebo to match Methotrexate capsule orally once per week

Other: Methotrexate Placebo

Interventions

AbataceptDRUG

Combination Therapy: Abatacept + Methotrexate

MethotrexateDRUG

Combination Therapy: Abatacept + MethotrexateMethotrexate treatment

Abatacept PlaceboOTHER

Abatacept Placebo

Methotrexate PlaceboOTHER

Methotrexate Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Rheumatoid arthritis (RA) diagnosis less than 6 months
CRP \> 3 mg/L or Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/h
At least 3 swollen and 3 tender joints
Anti-citrullinated protein antibodies (ACPA) positive

You may not qualify if:

At risk for tuberculosis
Have acute infection
Have chronic or recurrent bacterial or serious latent viral infection
History of malignancies in the last 5 years except squamous skin, basal skin or cervical carcinoma
Previous treatment with any conventional or biologic Disease-modifying anti rheumatic drugs (DMARD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Bristol-Myers Squibblead