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Completed

NCT Number: NCT02778906

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Klinikum Bad Abbach, Bad Abbach, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Abatacept

Drug

Administration of Abatacept s.c. 125mg/weekly according to the Label for Rheumatoid arthritis

Other names: Orencia

Placebo

Drug

Administration of the comparator s.c. weekly in comparable to verum

Other names: Comparator

Primary outcomes

  1. Proportion of patients with an improvement of acute inflammation characterised as improvement of synovitis (synovialitis or tenosynovitis) or osteitis in the MRI of the dominant hand after 6 months of treatment with abatacept or placebo

    Time frame: 6 months

Secondary outcomes

  1. RAMRIS synovitis score in the dominant hand 12 and 18 months.

    Time frame: 6,12,18 months

  2. Tenosynovitis score in the dominant hand.

    Time frame: 6,12,18 months

  3. Proportion of patients with new or persistent arthralgia.

    Time frame: 6,12,18 months

  4. Time to disappearance of arthralgia.

    Time frame: 6 months

  5. Proportion of patients with clinical arthritis defined by joint swelling

    Time frame: 6,12,18 months

  6. Proportion of patients with RA (ACR/EULAR 2010 criteria)

    Time frame: 6,12,18 months

  7. Proportion of patients with radiological progress in HR-pQCT analysis comparing baseline image with end of study image.

    Time frame: 18 months

  8. Tender Joint Count 68

    Time frame: 3,6,9,12,15 and 18 months

  9. Disease activity score (DAS) 28

    Time frame: 3,6,9,12,15 and 18 months

  10. Visual analogue scale (VAS) pain

    Time frame: 3,6,9,12,15 and 18 months

  11. Duration of joint stiffness

    Time frame: 3,6,9,12,15 and 18 months

  12. Health assessment Questionnaire (HAQ-DI)

    Time frame: 6,12 and 18 months

  13. Rheumatoid Arthritis Impact of Disease (RAID)

    Time frame: 6,12 and 18 months

  14. Short Form 36 (SF-36)

    Time frame: 6,12 and 18 months

  15. Bone mineral density (BMD)

    Time frame: 18 months

  16. Bone volume per tissue volume (BV/TV)

    Time frame: 18 months

  17. Cortical width in the micro-CT of the distal radius

    Time frame: 18 months

  18. Cortical porosity in the micro-CT of the distal radius

    Time frame: 18 months

  19. RAMRIS erosion score in the dominant hand 12 and 18 months.

    Time frame: 6. 12. 18 months

  20. RAMRIS osteitis score in the dominant hand 12 and 18 months.

    Time frame: 6,12,18 months

  21. Swollen Joint Count 68

    Time frame: 3,6,9,12,15 and 18 months

  22. Visual analogue scale (VAS) patient global

    Time frame: 3,6,9,12,15 and 18 months

  23. Visual analogue scale (VAS) physician global

    Time frame: 3,6,9,12,15 and 18 months

  24. Cortical width in the micro-CT of the metacarpal heads

    Time frame: 18 months

  25. Cortical porosity in the micro-CT of the metacarpal heads

    Time frame: 18 months

Sponsors and collaborators

Lead sponsor

University of Erlangen-Nürnberg Medical School

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Acronym: ARIAA

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
May 20, 2016
Registry last updated
Mar 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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