A Study in Rheumatoid Arthritis (RA) Patients to Compare Two Formulations of Adalimumab for Pharmacokinetic, Pharmacodynamic and Safety



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:Any
Updated:11/18/2012
Start Date:June 2012
End Date:March 2013
Contact:Nicky Mayber, BSN, MBA
Email:nicky.mayber@abbott.com
Phone:847-936-6362

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Study to Assess the Pharmacokinetic, Pharmacodynamic, Safety and Immunogenicity of a New Adalimumab Formulation in Subjects With Active Rheumatoid Arthritis


A study in Rheumatoid Arthritis (RA) patients to look at two formulations of adalimumab for
pharmacokinetic and safety.


Inclusion Criteria

1. Male or female subject, 18 years or older who has a diagnosis of Rheumatoid Arthritis
(RA) as defined by the 1987-revised American College of Rheumatology
(ACR)-classification criteria or the new American College of Rheumatology
(ACR)/European League Against Rheumatism (EULAR) diagnostic criteria for RA
2010-classification criteria and has a disease duration for a minimum of 3 months.

2. Subjects must be naïve to biologic therapy.

3. Subject must meet the following criteria for the joint assessment:

- At least 6 swollen joints out of 66 assessed.

- At least 6 tender joints out of 68 assessed.

4. Prior Disease Modifying Antirheumatic Drug (DMARD) therapy:

1. Subjects not on methotrexate at baseline must remain without methotrexate
throughout the study. Subjects on prior Methotrexate (MTX) must have
discontinued at least 28 days prior to Week 0 (Day 1).

2. Subjects on Disease Modifying Antirheumatic Drug (DMARD) therapy other than
Methotrexate (MTX) (except prednisone/prednisolone less than or equal to 10 mg)
must discontinue it for at least 28 days before the first dose of
investigational product at Week 0 (Day 1).

5. Female subjects are either not of childbearing potential, defined as postmenopausal
for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral
oophorectomy and/or hysterectomy), or are practicing at least 1 of the following
methods of birth control throughout the study and for at least 150 days after the
last dose of study drug:

- Condoms, sponge, foams, jellies, diaphragm or intrauterine device (IUD).

- Hormonal contraceptives for 90 days prior to study drug administration.

- Vasectomized partner(s).

6. Subjects must be able and willing to self-administer subcutaneous (SC) injections or
have a qualified person available to administer subcutaneous (SC) injections.

7. Subject is judged to be in good general health as determined by the Principal
Investigator based upon the results of medical history, physical examination,
laboratory profile, chest x-ray (CXR), and 12 lead electrocardiogram (ECG) performed
during Screening.

8. Subject has a negative Tuberculosis (TB) screening assessment (including a (Purified
Protein Derivative (PPD) test or QuantiFERON-Tuberculosis (TB) Gold test or
equivalent) and negative chest x-ray (Posterior-Anterior (PA) and lateral view) at
Screening. If a subject has evidence of a latent Tuberculosis (TB) infection, the
subject must initiate and complete a minimum of 2 weeks of anti-Tuberculosis (TB)
therapy or have documented completion of a course of anti-Tuberculosis (TB) therapy
prior to Baseline.

9. Subjects must be willing to provide written consent and to comply with the
requirements of this study protocol.

Exclusion Criteria

1. Subject has been treated with intra-articular or parenteral administration of
corticosteroids in the preceding 4 weeks from Baseline visit. Inhaled
corticosteroids for stable medical conditions are allowed. Oral of less than or
equal to 10 mg/d prednisone equivalent are allowed.

2. Subject has been treated with any investigational drug of a chemical or biological
nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug
prior to Baseline Visit.

3. Subject has a history of acute inflammatory joint disease of different origin other
than Rheumatoid Arthritis (RA) (e.g., seronegative spondyloarthropathy, psoriatic
arthritis, Reiter's syndrome, systemic lupus erythematosus, gouty arthritis, or any
arthritis with onset prior to age 17 years).

4. Known hypersensitivity to adalimumab or its excipients.

5. Subject currently uses or plans to use anti-retroviral therapy at any time during the
study.

6. History of demyelinating disease (including myelitis) or neurologic symptoms
suggestive of demyelinating disease.

7. History of invasive infection (e.g., listeriosis and histoplasmosis), human
immunodeficiency syndrome (HIV).

8. Chronic recurring infections or active Tuberculosis (TB).

9. History of moderate to severe congestive heart failure (New York Heart Association
(NYHA) class III or IV), recent cerebrovascular accident and any other condition
which, in the opinion of the investigator, would put the subject at risk by
participation in the protocol.

10. Evidence of dysplasia or history of malignancy (including lymphoma and leukemia)
other than a successfully treated non-metastatic cutaneous squamous cell or basal
cell carcinoma or localized carcinoma in situ of the cervix.

11. Subject received any live vaccine within 3 months prior to study drug administration.

12. Subject has a history of clinically significant hematologic (e.g., severe anemia,
leukopenia, thrombocytopenia), renal or liver disease (e.g., fibrosis, cirrhosis,
hepatitis).

13. Positive pregnancy test at Screening or Baseline.

14. Subject is considered by the investigator, for any reason, to be unsuitable candidate
for the study
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Charleston, South Carolina 29406
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Philadelphia, Pennsylvania 19152
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