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Clinical Trials/EUCTR2014-000555-93-DE
EUCTR2014-000555-93-DEActive, not recruitingPhase 1

Abatacept reversing subclinical Inflammation as measured by MRI in ACPA positive Arthralgia

niversity Hospital Erlangen0 sites98 target enrollmentStarted: May 26, 2014Last updated:
Conditions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Sponsor
Enrollment
98

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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
  • - Must understand and voluntarily sign an informed consent form including written consent for data protection
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 65
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 33

Exclusion Criteria

  • - Presence of arthritis in hand, feet, knee, shoulder or elbow joints defined as swelling
  • - Current treatment with glucocorticoids conventional or biologic DMARDs
  • - 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 patients or patients known to be HIV positive
  • - Uncontrolled severe concomitant disease
  • - Pregnant or lactating females
  • - 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

Investigators

Sponsor
niversity Hospital Erlangen

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