Overview

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

Status:
Completed

Trial end date:
2015-01-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Rüdiger B. Müller

Collaborator:

Bristol-Myers Squibb

Treatments:

Abatacept

Criteria

Inclusion Criteria:

1. Male or female subjects aged 18 years or older at the time of consent

2. Able to give informed consent

3. Patients classified as RA according to the 2010 American College of
Rheumatology/European League against Rheumatism (ACR/EULAR) criteria (Aletaha D et al,
2010)

4. Patient treated with weekly SC-Abatacept for at least 3 months prior to study
screening

5. Effective control of disease activity as defined by DAS-28 (ESR) < 3.2 (LDAS)

6. Available for the whole duration of the study

7. 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.

8. 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 Criteria:

1. Subjects who have previously received >2 biologic DMARDs

2. 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)

3. Subjects with active vasculitis of a major organ system, with the exception of
rheumatoid nodules

4. 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

5. 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

6. 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

7. Subjects with herpes zoster or cytomegalovirus (CMV) that resolved less than 2 months
before the informed consent document was signed

8. Subjects who have received any live vaccines within 3 months of the anticipated first
dose of study medication

9. Having participated in another drug or an interventional study within 30 days
preceding the present study screening