Introducing a Single IV Abatacept Treatment in RA Patients Currently Receiving Weekly SC Abatacept to Simulate a Holiday

NCT01846975 | Completed Phase 4 DMC

• 1 other identifier: A-BREAK
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

RA (rheumatoid arthritis) patients effectively treated weekly with SC (subcutaneous) Abatacept will be switched to IV (intravenous) Abatacept and restarted with SC Abatacept four after IV application. The investigators hypothesize that a switch from SC- to IV-abatacept and back in patients with low disease activity is safe and not associated with a worsening of the disease.

Conditions

Rheumatoid Arthritis

Keywords

Abatacept; Low disease activity; Intravenous; Subcutaneous; Rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• Is switching from weekly SC injections of Abatacept to a single IV injection to cover a 4-week period an effective treatment for maintaining the disease state of patients with RA.

  Percentage of patients remaining with or less than Low Disease Activity Score (LDAS (Machold KP et al, 2003).) at Day 28. LDAS is defined as a disease activity score-28 (DAS-28 (ESR) (Prevoo ML et al, 1995)) of less than 3.2. The DAS-28 (ESR) is defined by the number of tender and swollen joints calculated from 28 joints mainly from the upper limbs, the erythrocyte sedimentation rate (ESR) and the patient´s global assessment of disease activity (Wells, 2009).

  4 weeks

Secondary Outcomes (4)

• Is switching from SC- to IV-Abatacept and back within 1 month safe at 84 days after the IV-Abatacept treatment.

  84 days

• Is switching from SC- to IV-Abatacept and back within 1 month safe at 168 days after the IV-Abatacept treatment.

  168 days

• Is switching from SC- to IV-Abatacept and back within 1 month effective for maintaining the disease state of patients with RA at 84 days after the IV-Abatacept treatment.

  84 days

• Is switching from SC- to IV-Abatacept and back within 1 month effective for maintaining the disease state of patients with RA at 168 days after the IV-Abatacept treatment.

  168 days

Other Outcomes (1)

• Clinical disease activity and patient related outcome parameters over the study period Does IV-Abatacept pre-exposition influence the occurrence of AEs or the evolving disease activity

  168 days

Study Arms (1)

Switch from SC to IV Abatacept and back

EXPERIMENTAL

Transition from weekly SC- to a single IV-Abatacept but also the return to weekly SC treatments after a 4 week break.

Drug: IV Abatacept

Interventions

IV Abatacept DRUG

Transition from weekly SC- to a single IV-Abatacept but also the return to weekly SC treatments after a 4 week break.

Also known as: Switch from SC to IV Abatacept and back

Switch from SC to IV Abatacept and back

Eligibility Criteria

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

You may qualify if:

• Male or female subjects aged 18 years or older at the time of consent
• Able to give informed consent
• Patients classified as RA according to the 2010 American College of Rheumatology/European League against Rheumatism (ACR/EULAR) criteria (Aletaha D et al, 2010)
• Patient treated with weekly SC-Abatacept for at least 3 months prior to study screening
• Effective control of disease activity as defined by DAS-28 (ESR) \< 3.2 (LDAS)
• Available for the whole duration of the study
• Female subjects of childbearing potential must use maximally effective birth control during the period of therapy, must be willing to use contraception for the duration of the study (up to 168 days post the IV infusion of Abatacept). They also must have a negative pregnancy test upon entry into the study. Otherwise, female subjects must be postmenopausal (no menstrual period for a minimum of 12 months) or surgically sterile.
• Male subjects must be surgically sterile or willing to use a double barrier contraception method upon enrolment, for the duration of the study (up to 168 days post the IV infusion of Abatacept)

You may not qualify if:

• Subjects who have previously received \>2 biologic DMARDs
• Pregnant or breastfeeding women or such with a child-bearing potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy for the entire study period (up to Day 168/Safety follow-up visit)
• Subjects with active vasculitis of a major organ system, with the exception of rheumatoid nodules
• Subjects with current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, pulmonary, cardiac, neurologic, or cerebral disease, whether or not related to RA and which, in the opinion of the investigator, might place a subject at unacceptable risk for participation in the study
• Subjects with a history of cancer in the last 5 years, or with a current screening suspicious for cancer, other than non-melanoma skin cell cancers cured by local resection or carcinoma in situ
• Subjects with evidence of active or latent bacterial (e.g. tuberculosis) or viral infections (e.g. Human Immunodeficiency Virus (HIV) at the time of potential enrolment
• Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months before the informed consent document was signed
• Subjects who have received any live vaccines within 3 months of the anticipated first dose of study medication
• Having participated in another drug or an interventional study within 30 days preceding the present study screening

Sponsors & Collaborators

• Rüdiger B. Müller: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Related Publications (4)

• Genovese MC, Covarrubias A, Leon G, Mysler E, Keiserman M, Valente R, Nash P, Simon-Campos JA, Porawska W, Box J, Legerton C 3rd, Nasonov E, Durez P, Aranda R, Pappu R, Delaet I, Teng J, Alten R. Subcutaneous abatacept versus intravenous abatacept: a phase IIIb noninferiority study in patients with an inadequate response to methotrexate. Arthritis Rheum. 2011 Oct;63(10):2854-64. doi: 10.1002/art.30463.

  PMID: 21618201 BACKGROUND

• Kaine J, Gladstein G, Strusberg I, Robles M, Louw I, Gujrathi S, Pappu R, Delaet I, Pans M, Ludivico C. Evaluation of abatacept administered subcutaneously in adults with active rheumatoid arthritis: impact of withdrawal and reintroduction on immunogenicity, efficacy and safety (phase Iiib ALLOW study). Ann Rheum Dis. 2012 Jan;71(1):38-44. doi: 10.1136/annrheumdis-2011-200344. Epub 2011 Sep 13.

  PMID: 21917824 BACKGROUND

• Keystone EC, Kremer JM, Russell A, Box J, Abud-Mendoza C, Elizondo MG, Luo A, Aranda R, Delaet I, Swanink R, Gujrathi S, Luggen M. Abatacept in subjects who switch from intravenous to subcutaneous therapy: results from the phase IIIb ATTUNE study. Ann Rheum Dis. 2012 Jun;71(6):857-61. doi: 10.1136/annrheumdis-2011-200355. Epub 2012 Feb 2.

  PMID: 22302417 BACKGROUND

• Mueller RB, Gengenbacher M, Richter S, Dudler J, Moller B, von Kempis J. Change from subcutaneous to intravenous abatacept and back in patients with rheumatoid arthritis as simulation of a vacation: a prospective phase IV, open-label trial (A-BREAK). Arthritis Res Ther. 2016 Apr 14;18:88. doi: 10.1186/s13075-016-0985-2.

  PMID: 27074795 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ruediger B Mueller, MD

  Cantonal Hospital of St. Gallen

  STUDY CHAIR

• Johannes von Kempis, Prof.

  Cantonal Hospital of St. Gallen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Oberarzt mbF

Study Record Dates

• First Submitted: April 19, 2013
• First Posted: May 6, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 4, 2015

Record last verified: 2015-03

Locations

CH (1)