Back to resultsAbatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia (ARIAA)
Primary Purpose
Arthralgia, Arthritis
Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Abatacept
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Arthralgia focused on measuring Abatacept
Eligibility 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).
Sites / Locations
- Klinikum Bad Abbach
- Charite Berlin
- Praxis für Rheumatologie und Innere Medizin
- Clinic Burghausen
- University Clinic Erlangen
- Centrum für innovative Diagnostik und Therapie (Ciri) Rheumatologie/Immunologie
- Universitätsklinik Freiburg
- Rheumazentrum Ruhrgebiet
- Krankenhaus Porz Am Rhein
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Abatacept
Placebo
Arm Description
Abatacept 125 mg s.c. weekly
Placebo (NaCl 0,9%) s.c. weekly
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
RAMRIS synovitis score in the dominant hand 12 and 18 months.
Tenosynovitis score in the dominant hand.
Proportion of patients with new or persistent arthralgia.
Time to disappearance of arthralgia.
Proportion of patients with clinical arthritis defined by joint swelling
Proportion of patients with RA (ACR/EULAR 2010 criteria)
Proportion of patients with radiological progress in HR-pQCT analysis comparing baseline image with end of study image.
Tender Joint Count 68
Disease activity score (DAS) 28
Visual analogue scale (VAS) pain
Duration of joint stiffness
Health assessment Questionnaire (HAQ-DI)
Rheumatoid Arthritis Impact of Disease (RAID)
Short Form 36 (SF-36)
Bone mineral density (BMD)
Bone volume per tissue volume (BV/TV)
Cortical width in the micro-CT of the distal radius
Cortical porosity in the micro-CT of the distal radius
RAMRIS erosion score in the dominant hand 12 and 18 months.
RAMRIS osteitis score in the dominant hand 12 and 18 months.
Swollen Joint Count 68
Visual analogue scale (VAS) patient global
Visual analogue scale (VAS) physician global
Cortical width in the micro-CT of the metacarpal heads
Cortical porosity in the micro-CT of the metacarpal heads
Full Information
NCT ID
NCT02778906
First Posted
February 2, 2015
Last Updated
March 9, 2020
Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT02778906
Brief Title
Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia
Acronym
ARIAA
Official Title
Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia (ARIAA)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School
Collaborators
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthralgia, Arthritis
Keywords
Abatacept
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
98 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Abatacept
Arm Type
Active Comparator
Arm Description
Abatacept 125 mg s.c. weekly
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (NaCl 0,9%) s.c. weekly
Intervention Type
Drug
Intervention Name(s)
Abatacept
Other Intervention Name(s)
Orencia
Intervention Description
Administration of Abatacept s.c. 125mg/weekly according to the Label for Rheumatoid arthritis
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Comparator
Intervention Description
Administration of the comparator s.c. weekly in comparable to verum
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
RAMRIS synovitis score in the dominant hand 12 and 18 months.
Time Frame
6,12,18 months
Title
Tenosynovitis score in the dominant hand.
Time Frame
6,12,18 months
Title
Proportion of patients with new or persistent arthralgia.
Time Frame
6,12,18 months
Title
Time to disappearance of arthralgia.
Time Frame
6 months
Title
Proportion of patients with clinical arthritis defined by joint swelling
Time Frame
6,12,18 months
Title
Proportion of patients with RA (ACR/EULAR 2010 criteria)
Time Frame
6,12,18 months
Title
Proportion of patients with radiological progress in HR-pQCT analysis comparing baseline image with end of study image.
Time Frame
18 months
Title
Tender Joint Count 68
Time Frame
3,6,9,12,15 and 18 months
Title
Disease activity score (DAS) 28
Time Frame
3,6,9,12,15 and 18 months
Title
Visual analogue scale (VAS) pain
Time Frame
3,6,9,12,15 and 18 months
Title
Duration of joint stiffness
Time Frame
3,6,9,12,15 and 18 months
Title
Health assessment Questionnaire (HAQ-DI)
Time Frame
6,12 and 18 months
Title
Rheumatoid Arthritis Impact of Disease (RAID)
Time Frame
6,12 and 18 months
Title
Short Form 36 (SF-36)
Time Frame
6,12 and 18 months
Title
Bone mineral density (BMD)
Time Frame
18 months
Title
Bone volume per tissue volume (BV/TV)
Time Frame
18 months
Title
Cortical width in the micro-CT of the distal radius
Time Frame
18 months
Title
Cortical porosity in the micro-CT of the distal radius
Time Frame
18 months
Title
RAMRIS erosion score in the dominant hand 12 and 18 months.
Time Frame
6. 12. 18 months
Title
RAMRIS osteitis score in the dominant hand 12 and 18 months.
Time Frame
6,12,18 months
Title
Swollen Joint Count 68
Time Frame
3,6,9,12,15 and 18 months
Title
Visual analogue scale (VAS) patient global
Time Frame
3,6,9,12,15 and 18 months
Title
Visual analogue scale (VAS) physician global
Time Frame
3,6,9,12,15 and 18 months
Title
Cortical width in the micro-CT of the metacarpal heads
Time Frame
18 months
Title
Cortical porosity in the micro-CT of the metacarpal heads
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Schett, Prof. Dr. univ.
Organizational Affiliation
University Clinic Erlangen, Department of Internal Medicine 3, Rheumatology & Immunology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinikum Bad Abbach
City
Bad Abbach
Country
Germany
Facility Name
Charite Berlin
City
Berlin
Country
Germany
Facility Name
Praxis für Rheumatologie und Innere Medizin
City
Berlin
Country
Germany
Facility Name
Clinic Burghausen
City
Burghausen
Country
Germany
Facility Name
University Clinic Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Centrum für innovative Diagnostik und Therapie (Ciri) Rheumatologie/Immunologie
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany
Facility Name
Universitätsklinik Freiburg
City
Freiburg
Country
Germany
Facility Name
Rheumazentrum Ruhrgebiet
City
Herne
Country
Germany
Facility Name
Krankenhaus Porz Am Rhein
City
Koeln
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Abatacept Reversing Subclinical Inflammation as Measured by MRI in ACPA Positive Arthralgia
We'll reach out to this number within 24 hrs