Status:
COMPLETED
Introducing a Single IV Abatacept Treatment in RA Patients Currently Receiving Weekly SC Abatacept to Simulate a Holiday
Lead Sponsor:
Rüdiger B. Müller
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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....
Detailed Description
Abatacept is a recombinant fusion protein composed of the Fc region of the Immunoglobulin IgG1 fused to the extracellular domain human cytotoxic T-Lymphocyte Antigen 4 (CTLA-4) modified to prevent ant...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01846975
Start Date
May 1 2013
End Date
January 1 2015
Last Update
March 4 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland, 9007