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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 12 December 2020
Main ID:  NCT02053727
Date of registration: 06/11/2013
Prospective Registration: Yes
Primary sponsor: University of California, Los Angeles
Public title: Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background RA
Scientific title: Pilot Study to Evaluate Subcutaneous Abatacept vs Placebo in RA Patients With Hepatitis B on Entecavir Background- a Pilot, Double-blind, Placebo-controlled, Randomized, Controlled Trial.
Date of first enrolment: July 2014
Target sample size: 0
Recruitment status: Withdrawn
URL:  https://clinicaltrials.gov/show/NCT02053727
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).  
Phase:  N/A
Countries of recruitment
United States
Contacts
Name:     Suzanne Kafaja, M.D.
Address: 
Telephone:
Email:
Affiliation:  University of California, Los Angeles
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of RA.

2. Baseline CDAI >10 with TJC (Tender Joint Count) > 4 and SJC (Swollen Joint Count) > 2.

3. Chronic Hepatitis B as defined by a history of patients with a HBsAg positive for at
least 6 months with undetectable HBV DNA; or a history of patients with negative HBsAg
and positive HBcAb or HBsAb, with undetectable HBV DNA.

4. No evidence of hepatocellular carcinoma (HCC) based upon alpha-fetoprotein (AFP) =20
ng/mL at screening,) negative liver imaging as shown by ultrasound, computerized
tomography or magnetic resonance imaging within 24 weeks of screening. Participants
with AFP >20 ng/mL must be evaluated clinically with additional imaging and shown not
to have HCC on CT or MRI before they can be enrolled.

5. Oral corticosteroids (= 10 mg/day of prednisone or equivalent) and NSAIDs
(Non-Steroidal Anti-inflammatory Drugs) are permitted if the patient is on a stable
dose regimen for = 2 weeks prior to and including at baseline.

6. Men and women, >= 18 years of age.

Exclusion Criteria:

1. Women who are pregnant or breastfeeding. Sexually active fertile men not using
effective birth control if their partners are WOCBP (Women of Child Bearing
Potential).

2. Target Disease Exceptions

a) Rheumatic autoimmune disease other than RA; fibromyalgia or
keratoconjunctivitis/xerostomia are allowed, as long as these will not confound the
CLINICAL EFFICACY OUTCOMES.

3. Medical History and Concurrent Diseases

1. Subjects who are impaired, incapacitated, or incapable of completing
study-related assessments.

2. Subjects who underwent previous MCP (metacarpophalangeal) arthroplasty, have such
a procedure scheduled, or anticipate the need for such a procedure during the
study.

3. Major surgery (including joint surgery) within 8 weeks prior to screening

4. Subjects with active vasculitis of a major organ system, with the exception of
rheumatoid nodules or minor rheumatoid vasculitis lesions of the skin

5. Subjects with current uncontrolled symptoms of severe, progressive, or
uncontrolled renal, hepatic hematologic, gastrointestinal, pulmonary, cardiac,
neurologic, or cerebral disease, including Cirrhosis with Child-Pugh Class >=2 or
COPD (chronic obstructive pulmonary disease) with FEV1 (forced expiratory volume
in 1 second) /FVC (forced vital capacity) < 0.6

6. Female subjects who have had a recent breast cancer screening that is suspicious
for malignancy and where the diagnosis is not excluded.

h) Subjects who currently abuse drugs or alcohol. i) Subjects with evidence of active
or latent bacterial or viral infections at the time of potential enrollment, including
HIV.

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

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

l) Subjects with any serious bacterial infection within the last 3 months, unless
treated and resolved with antibiotics, or any chronic bacterial infection.

m) Subjects at risk for tuberculosis (TB) or not treated for latent TB is tested
positive.

n) Subjects who are positive for hepatitis C antibody if the presence of hepatitis C
virus was also shown with polymerase chain reaction or recombinant immunoblot assay.

o) Subjects who have abnormal laboratory values

4. Prohibited Treatments and/or Therapies

1. Subjects who have at any time received treatment with any investigational drug
within 28 days (or less than 5 terminal half-lives of elimination) of the Day 1
dose.

2. Any concomitant biologic DMARD, such as anakinra.

3. Previous treatment with cell-depleting therapies, including investigational
agents, including but not limited to CAMPATH, anti-CD4 (cluster of
differentiation 4), anti-CD5, anti-CD3, and anti-CD19.

4. Anti-CD20 treatment within the last 6 months (OK to include if they were dosed >
6 months ago).

5. Treatment with methotrexate, hydroxychloroquine, cyclosporine A, azathioprine,
mycophenolate mofetil, within <= 4 weeks prior to baseline.

6. Treatment with etanercept within 2 weeks,
infliximab/certolizumab/golimumab/adalimumab with <=8 weeks, anakinra within <=1
week prior to baseline.

7. Previous abatacept use.

8. Treatment with sulfasalazine within < 4 weeks prior to baseline



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Chronic Hepatitis B
Rheumatoid Arthritis
Intervention(s)
Drug: Abatacept
Drug: Placebo
Primary Outcome(s)
Number of Participants with Serious Adverse Events [Time Frame: Every 4 weeks from Week 4 to Week 48]
Number of Subjects with Hepatitis B Reactivation [Time Frame: Every 4 Weeks from Week 4 to Week 48]
Secondary Outcome(s)
ACR 20/50/70 Percentage [Time Frame: Screening, Weeks 4,8,12,24,36,48]
CDAI Unit [Time Frame: Screening, Weeks 4,8,12,24,36,48]
DAS28-ESR-4 Unit [Time Frame: Screening, Weeks 4, 8, 12, 24, 36, and 48]
Fatigue (as assessed by FACIT-Fatigue Unit) [Time Frame: Screening, Weeks 4,8,12,24,36,48]
Global Assessment of Disease Activity (as measured on a 5 point Likert scale) [Time Frame: Screening, Weeks 4,8,12,24,36,48]
HAQ-DI Units [Time Frame: Screening, Weeks 4,8,12,24,36,48]
MD Global (Visual Analogue Scale) [Time Frame: Screening, Weeks 4,8,12,24,36,48]
Pain (measured on a 5 point Likert scale) [Time Frame: Screening, Weeks 4,8,12,24,36,48]
Patient Global (Visual Analogue Scale) [Time Frame: Screening, Weeks 4,8,12,24,36,48]
SJC Count [Time Frame: Screening, Weeks 4,8,12,24,36,48]
Sleep as assessed by Medical Outcomes Study Sleep Instrument Unit [Time Frame: Screening, Weeks 4,8,12,24,36,48]
TJC Count [Time Frame: Screening, Weeks 4,8,12,24,36,48]
Secondary ID(s)
13-001279
IM101329
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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