Abatacept
DrugAdministration of Abatacept s.c. 125mg/weekly according to the Label for Rheumatoid arthritis
Other names: Orencia
NCT Number: NCT02778906
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.
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Notify Me18 year and older
All sexes
Interventional
Phase 3
Klinikum Bad Abbach, Bad Abbach, Germany
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administration of Abatacept s.c. 125mg/weekly according to the Label for Rheumatoid arthritis
Other names: Orencia
Administration of the comparator s.c. weekly in comparable to verum
Other names: Comparator
Time frame: 6 months
Time frame: 6,12,18 months
Time frame: 6,12,18 months
Time frame: 6,12,18 months
Time frame: 6 months
Time frame: 6,12,18 months
Time frame: 6,12,18 months
Time frame: 18 months
Time frame: 3,6,9,12,15 and 18 months
Time frame: 3,6,9,12,15 and 18 months
Time frame: 3,6,9,12,15 and 18 months
Time frame: 3,6,9,12,15 and 18 months
Time frame: 6,12 and 18 months
Time frame: 6,12 and 18 months
Time frame: 6,12 and 18 months
Time frame: 18 months
Time frame: 18 months
Time frame: 18 months
Time frame: 18 months
Time frame: 6. 12. 18 months
Time frame: 6,12,18 months
Time frame: 3,6,9,12,15 and 18 months
Time frame: 3,6,9,12,15 and 18 months
Time frame: 3,6,9,12,15 and 18 months
Time frame: 18 months
Time frame: 18 months
University of Erlangen-Nürnberg Medical School
Other
Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia (ARIAA)
Acronym: ARIAA
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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