Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia (ARIAA)

University of Erlangen-Nürnberg Medical School

Status and phase

Completed

Phase 3

Conditions

Arthritis

Arthralgia

Treatments

Drug: Placebo

Drug: Abatacept

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02778906

IM101-477

Details and patient eligibility

About

This is a randomised double-blinded placebo-controlled multi centre study in 98 patients with ACPA positive arthralgia. The study is composed of 2 arms with a 1:1 randomisation at baseline: Treatment phase will be 6 months. Group 1: Abatacept s.c. 125 mg weekly for 6 months vs. Group 2: Placebo s.c. for 6 months. After 6 months both groups will run into the follow up period for another 12 months up to month 18. Patients developing arthritis will be treated according to local guidelines.

Enrollment

98 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Females and males aged ≥ 18 years at time of consent
ACPA (with or without RF)
Joint pain (hand, feet, knee, shoulder or elbow) present for at least 6 weeks prior to inclusion or in past history
Presence of synovitis (synovialitis or tenosynovitis) or osteitis in MRI of the dominant hand at baseline
Women of childbearing potential or men capable of fathering children must be using effective contraception during treatment with abatacept and up to 14 weeks after the last dose of abatacept treatment.
Must understand and voluntarily sign an informed consent form including written consent for data protection
Must be able to adhere to the study visit schedule and other protocol requirements

Exclusion criteria

Presence of arthritis in hand, feet, knee, shoulder or elbow joints defined as swelling
Current treatment with glucocorticoids conventional or biologic DMARDs
Previous treatment with abatacept
Investigational study drug within 4 weeks (or 5 half lives, whichever is longer) prior to randomization
Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
Any other autoimmune or inflammatory disease such as SLE, PSS, MCTD, SpA, Behcet disease, vasculitis or autoimmune hepatitis.
Any malignancy in the last 5 years
Chronic infection such as latent TB (TB not adequately treated according to guidelines) or hepatitis B or C infection
Immunocompromised or HIV-positive patients
Uncontrolled severe concomitant disease
Patients who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 and Abs. 3 AMG).
Pregnant or lactating females
Patients who possibly are dependent on the Principal Investigator or Investigator (e.g. family members).