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

NCT02778906 | Completed Phase 3 DMC

• 1 other identifier: IM101-477
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 9

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.

Conditions

Arthralgia; Arthritis

Keywords

Abatacept

Outcome Measures

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

  6 months

Secondary Outcomes (25)

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

  6,12,18 months

• Tenosynovitis score in the dominant hand.

  6,12,18 months

• Proportion of patients with new or persistent arthralgia.

  6,12,18 months

• Time to disappearance of arthralgia.

  6 months

• Proportion of patients with clinical arthritis defined by joint swelling

  6,12,18 months

Study Arms (2)

Abatacept

ACTIVE COMPARATOR

Abatacept 125 mg s.c. weekly

Drug: Abatacept

Placebo

PLACEBO COMPARATOR

Placebo (NaCl 0,9%) s.c. weekly

Drug: Placebo

Interventions

Abatacept DRUG

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

Also known as: Orencia

Abatacept

Placebo DRUG

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

Also known as: Comparator

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Females and males aged ≥ 18 years at time of consent
• ACPA (with or without RF)
• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead
• Bristol-Myers Squibb: collaborator

Study Sites (9)

Klinikum Bad Abbach

Bad Abbach, Germany

Location

Charite Berlin

Berlin, Germany

Location

Praxis für Rheumatologie und Innere Medizin

Berlin, Germany

Location

Clinic Burghausen

Burghausen, Germany

Location

Krankenhaus Porz Am Rhein

Cologne, Germany

Location

University Clinic Erlangen

Erlangen, 91054, Germany

Location

Centrum für innovative Diagnostik und Therapie (Ciri) Rheumatologie/Immunologie

Frankfurt, 60528, Germany

Location

Universitätsklinik Freiburg

Freiburg im Breisgau, Germany

Location

Rheumazentrum Ruhrgebiet

Herne, Germany

Location

MeSH Terms

Conditions

Arthralgia; Arthritis

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Georg Schett, Prof. Dr. univ.

  University Clinic Erlangen, Department of Internal Medicine 3, Rheumatology & Immunology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2015
• First Posted: May 20, 2016
• Study Start: November 1, 2014
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 10, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

DE (9)