Effects of Abatacept in Patients With Early Rheumatoid Arthritis

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223027

Enrollment

1000

Registered

2015-11-26

Start date

2015-11-26

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Rheumatoid Arthritis

Interventions

investigational material(s) Generic name etc : Abatacept + Methotrexate INN of investigational material : Abatacept + Methotrexate Therapeutic category code : 399 Agents affecting metabolism, n.e.c. D

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Rheumatoid arthritis (RA) diagnosis less than 6 months CRP greater than 3 mg/L or Erythrocyte Sedimentation Rate (ESR) not less than 28 mm/h At least 3 swollen and 3 tender joints Anti-citrullinated protein antibodies (ACPA) positive

Exclusion criteria

Exclusion criteria: 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)

Design outcomes

Primary

Measure	Time frame
efficacy confirmatory Proportion of subjects in Simple Disease Activity Index (SDAI) remission [ Time Frame: Week 24 ] [ Designated as safety issue: No ]	—

Secondary

Measure	Time frame
safety efficacy confirmatory exploratory pharmacokinetics Proportion of subjects in Disease Activity Index (DAS)28 - c-reactive protein (CRP) remission [ Time Frame: Week 24 ] [ Designated as safety issue: No ] Proportion of subjects in SDAI remission [ Time Frame: Week 52 ] [ Designated as safety issue: No ] Mean change from baseline in radiographic progression of joint damage [ Time Frame: Week 52 ] [ Designated as safety issue: No ] Proportion of subjects in Boolean remission [ Time Frame: Week 52 ] [ Designated as safety issue: No ]	—

Measure

Time frame

safety efficacy confirmatory exploratory pharmacokinetics Proportion of subjects in Disease Activity Index (DAS)28 - c-reactive protein (CRP) remission [ Time Frame: Week 24 ] [ Designated as safety issue: No ] Proportion of subjects in SDAI remission [ Time Frame: Week 52 ] [ Designated as safety issue: No ] Mean change from baseline in radiographic progression of joint damage [ Time Frame: Week 52 ] [ Designated as safety issue: No ] Proportion of subjects in Boolean remission [ Time Frame: Week 52 ] [ Designated as safety issue: No ]

—

Countries

Africa, Asia except Japan, Europe, Japan, North America, Oceania, South America

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026