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

Arthritis Clinical Trial

— ARIAA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02778906
• Other study ID #: IM101-477
• Status: Completed
• Phase: Phase 3
• Start date: November 2014
• Est. completion date: December 2019

Study information

• Verified date: March 2020
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Arthralgia
• Arthritis
• Inflammation

Intervention

Drug:
• Abatacept
Administration of Abatacept s.c. 125mg/weekly according to the Label for Rheumatoid arthritis
• Placebo
Administration of the comparator s.c. weekly in comparable to verum

Locations

Country	Name	City	State
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	Centrum für innovative Diagnostik und Therapie (Ciri) Rheumatologie/Immunologie	Frankfurt
Germany	Universitätsklinik Freiburg	Freiburg
Germany	Rheumazentrum Ruhrgebiet	Herne
Germany	Krankenhaus Porz Am Rhein	Koeln

Sponsors (2)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School	Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		6 months
Secondary	RAMRIS synovitis score in the dominant hand 12 and 18 months.		6,12,18 months
Secondary	Tenosynovitis score in the dominant hand.		6,12,18 months
Secondary	Proportion of patients with new or persistent arthralgia.		6,12,18 months
Secondary	Time to disappearance of arthralgia.		6 months
Secondary	Proportion of patients with clinical arthritis defined by joint swelling		6,12,18 months
Secondary	Proportion of patients with RA (ACR/EULAR 2010 criteria)		6,12,18 months
Secondary	Proportion of patients with radiological progress in HR-pQCT analysis comparing baseline image with end of study image.		18 months
Secondary	Tender Joint Count 68		3,6,9,12,15 and 18 months
Secondary	Disease activity score (DAS) 28		3,6,9,12,15 and 18 months
Secondary	Visual analogue scale (VAS) pain		3,6,9,12,15 and 18 months
Secondary	Duration of joint stiffness		3,6,9,12,15 and 18 months
Secondary	Health assessment Questionnaire (HAQ-DI)		6,12 and 18 months
Secondary	Rheumatoid Arthritis Impact of Disease (RAID)		6,12 and 18 months
Secondary	Short Form 36 (SF-36)		6,12 and 18 months
Secondary	Bone mineral density (BMD)		18 months
Secondary	Bone volume per tissue volume (BV/TV)		18 months
Secondary	Cortical width in the micro-CT of the distal radius		18 months
Secondary	Cortical porosity in the micro-CT of the distal radius		18 months
Secondary	RAMRIS erosion score in the dominant hand 12 and 18 months.		6. 12. 18 months
Secondary	RAMRIS osteitis score in the dominant hand 12 and 18 months.		6,12,18 months
Secondary	Swollen Joint Count 68		3,6,9,12,15 and 18 months
Secondary	Visual analogue scale (VAS) patient global		3,6,9,12,15 and 18 months
Secondary	Visual analogue scale (VAS) physician global		3,6,9,12,15 and 18 months
Secondary	Cortical width in the micro-CT of the metacarpal heads		18 months
Secondary	Cortical porosity in the micro-CT of the metacarpal heads		18 months