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
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