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

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ClinicalTrials.gov Identifier: NCT02778906
Recruitment Status : Completed
First Posted : May 20, 2016
Last Update Posted : March 10, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Arthralgia Arthritis Drug: Abatacept Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia (ARIAA)
Study Start Date : November 2014
Actual Primary Completion Date : December 2019
Actual Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arthritis
Drug Information available for: Abatacept

Arm Intervention/treatment
Active Comparator: Abatacept
Abatacept 125 mg s.c. weekly
Drug: Abatacept
Administration of Abatacept s.c. 125mg/weekly according to the Label for Rheumatoid arthritis
Other Name: Orencia

Placebo Comparator: Placebo
Placebo (NaCl 0,9%) s.c. weekly
Drug: Placebo
Administration of the comparator s.c. weekly in comparable to verum
Other Name: Comparator




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02778906


Locations
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Germany
Klinikum Bad Abbach
Bad Abbach, Germany
Charite Berlin
Berlin, Germany
Praxis für Rheumatologie und Innere Medizin
Berlin, Germany
Clinic Burghausen
Burghausen, Germany
University Clinic Erlangen
Erlangen, Germany, 91054
Centrum für innovative Diagnostik und Therapie (Ciri) Rheumatologie/Immunologie
Frankfurt, Germany, 60528
Universitätsklinik Freiburg
Freiburg, Germany
Rheumazentrum Ruhrgebiet
Herne, Germany
Krankenhaus Porz Am Rhein
Koeln, Germany
Sponsors and Collaborators
University of Erlangen-Nürnberg Medical School
Bristol-Myers Squibb
Investigators
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Principal Investigator: Georg Schett, Prof. Dr. univ. University Clinic Erlangen, Department of Internal Medicine 3, Rheumatology & Immunology
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Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT02778906    
Other Study ID Numbers: IM101-477
First Posted: May 20, 2016    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of Erlangen-Nürnberg Medical School:
Abatacept
Additional relevant MeSH terms:
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Arthralgia
Inflammation
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Abatacept
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents