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A Randomized, Head-to-head, Single-blind Study to Compare the Response to Treatment with Subcutaneous Abatacept vs Adalimumab, on Background Methotrexate, in Adults with Early, Seropositive Rheumatoid Arthritis Who Have "Shared Epitope" HLA Class II Risk Alleles and Have an Inadequate Response to Methotrexate

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-506450-20-00
Acronym
IM101-863
Enrollment
141
Registered
2024-01-26
Start date
2021-11-05
Completion date
Unknown
Last updated
2025-12-10

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

Conditions

Rheumatoid Arthritis

Brief summary

Proportion of SE+ participants meeting ACR50 response at Week 24

Detailed description

Proportion of SE+ participants achieving DAS28-CRP remission (DAS28-CRP < 2.6) at Week 24, Proportion of whole study population participants meeting ACR50 response at Week 24, Proportion of SE+ participants achieving CDAI remission (CDAI ≤ 2.8) at Week 24, Mean change from baseline in SE+ participant-reported pain (VAS) at Week 24, Proportion of SE+ subset and whole population achieving ACR20/50/70 responses, DAS remission, CDAI remission, SDAI remission over the SBTP and OLTP; mean changes from baseline in DAS28-CRP, CDAI, SDAI over the SBTP and OLTP; mean changes from baseline in the 7 ACR core components over the SBTP and OLTP, Mean change from baseline in SF-36 in SE+ subset and whole population at Week 24 and Week 104 (4 physical and 4 mental subscales and the physical component and mental component summary)

Interventions

DRUGAbatacept
DRUGHumira 40 mg solution for injection in pre-filled syringe

Sponsors

Bristol-Myers Squibb Services Unlimited Company
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of SE+ participants meeting ACR50 response at Week 24—

Secondary

MeasureTime frame
Proportion of SE+ participants achieving DAS28-CRP remission (DAS28-CRP < 2.6) at Week 24, Proportion of whole study population participants meeting ACR50 response at Week 24, Proportion of SE+ participants achieving CDAI remission (CDAI ≤ 2.8) at Week 24, Mean change from baseline in SE+ participant-reported pain (VAS) at Week 24, Proportion of SE+ subset and whole population achieving ACR20/50/70 responses, DAS remission, CDAI remission, SDAI remission over the SBTP and OLTP; mean changes from baseline in DAS28-CRP, CDAI, SDAI over the SBTP and OLTP; mean changes from baseline in the 7 ACR core components over the SBTP and OLTP, Mean change from baseline in SF-36 in SE+ subset and whole population at Week 24 and Week 104 (4 physical and 4 mental subscales and the physical component and mental component summary)—

Countries

Czechia, France, Germany, Italy, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026