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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.
Last refreshed on: 12 December 2020
Main ID:  NCT02353780
Date of registration: 30/06/2013
Prospective Registration: Yes
Primary sponsor: Dr. Larry W. Moreland
Public title: Mechanistic Studies of B- and T-Cell Function in RA Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept MAZERATI
Scientific title: Mechanistic Studies of B- and T-Cell Function in Rheumatoid Arthritis Patients Treated With TNF Antagonists, Tocilizumab, or Abatacept
Date of first enrolment: March 2015
Target sample size: 10
Recruitment status: Terminated
Study type:  Interventional
Study design:  Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Single (Outcomes Assessor).  
Phase:  Phase 4
Countries of recruitment
United States
Name:     Larry W. Moreland, MD
Affiliation:  University of Pittsburgh
Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of RA by a physician as defined by the 1987 and/or 2010 ACR criteria.

- 18 years of age or less than or equal to 64 at the time of diagnosis of RA.

- RA Disease Activity CDAI > 10

- If using oral corticosteroids, must have been on stable dose (= 10 mg/day) for at
least 2 weeks prior to study drug initiation.

- PPD negative or if PPD positive documentation of therapy with INH for at least 1 month
prior to study initiation and negative chest x-ray.

- Must have been treated within the past year with either methotrexate (MTX),
leflunomide (LEF), hydrochloroquine (HCQ) and/or sulfasalazine (SSZ) for = 3 months.

- Prior or concurrent use of other oral DMARD therapy, including MTX, leflunomide, SSZ,
and HCQ, is permitted. Patients taking oral DMARDs must be on stable doses of DMARDs
for at least 4 weeks prior to study drug initiation. Subjects are not required to be
taking an oral DMARD.

Exclusion Criteria:

- Use of cyclophosphamide, penicillamine, cyclosporine A, tacrolimus or gold therapy is
not permitted in the 6 months prior to enrollment.

- Patients who are using or have used other biologic agents or tofacitinib concomitantly
or prior to this study

- History of active and/or chronic infection such as hepatitis, pneumonia,
pyelonephritis,herpetic infections or chronic skin infections and any active
opportunistic infection, including but not limited to evidence of active
cytomegalovirus, active Pneumocystis carinii, aspergillosis, histoplasmosis or
atypical mycobacterium infection.

- Active TB or evidence of latent TB (positive PPD skin test or a history of old or
latent TB on chest x-ray) without adequate therapy for TB.

- Pregnant or lactating women.

- Patients with current signs or symptoms of uncontrolled renal, gastrointestinal,
endocrine, pulmonary, cardiac, neurologic or cerebral disease.

- Diagnosis of liver disease or elevated hepatic enzymes, as defined by ALT, AST or both
>1.5 x the upper limit of normal (ULN) or total bilirubin > ULN.

- Any of the following hematologic abnormalities, confirmed by repeat tests:

1. White blood count < 3,000/µL or > 14,000/µL

2. Lymphocyte count <500/µL

3. Platelet count < 100,000/µL

4. Hemoglobin < 8.0 g/dL

5. Neutrophil count < 2,000 cells/µL

- Major surgery (including joint surgery) within 8 weeks prior to screening or planned
major surgery within 6 months following randomization.

- Immunization with a live/attenuated vaccine within 2 months prior to baseline or 3
months of last study visit.

- History of severe allergic or anaphylactic reactions to human, humanized, or murine
monoclonal antibodies

- History of other malignancy within 5 years prior to screening, except for
appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or
Stage I uterine cancer

- Patients with reproductive potential not willing to use an effective method of

- History of alcohol, drug or chemical abuse with 1 year prior to screening

Age minimum: 18 Years
Age maximum: 64 Years
Gender: All
Health Condition(s) or Problem(s) studied
Rheumatoid Arthritis (RA)
Drug: Abatacept
Drug: TNF Antagonist (enbrel, humire, remicade, cimzia, symponi)
Drug: Tocilizumab
Primary Outcome(s)
Mechanistic Comparisons (Changes in Frequencies of Peripheral Blood Immune Cell Subsets Following Institution of a Subcutaneously Administered TNF Antagonist, Tocilizumab or Abatacept.) [Time Frame: 0 to 3 months]
Secondary Outcome(s)
ACR20, 50, and 70 Response [Time Frame: 3 month and 6 month]
Adherence [Time Frame: 3 month and 6 month]
Corticosteroid Use [Time Frame: 3 month and 6 month]
DMARD Use [Time Frame: 3 month and 6 month]
Efficacy (CDAI) [Time Frame: 0 to 3 months]
Efficacy (DAS) [Time Frame: 3 month and 6 month]
Efficacy (EULAR) [Time Frame: 3 month and 6 month]
Reason for Discontinuation of Treatment [Time Frame: 3 month and 6 month]
Steroid Use [Time Frame: 3 month and 6 month]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Bristol-Myers Squibb
Genentech, Inc.
Ethics review
Results available: Yes
Date Posted: 01/10/2020
Date Completed:
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