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

Last updated: June 10, 2014
Sponsor: AbbVie (prior sponsor, Abbott)
Overall Status: Completed

Phase

2

Condition

Bone Diseases

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Treatment

N/A

Clinical Study ID

NCT01712178
M13-390
2012-000535-36
  • Ages > 18
  • All Genders

Study Summary

A study in Rheumatoid Arthritis (RA) patients to evaluate two formulations of adalimumab for pharmacodynamics, pharmacokinetics, and safety.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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.

  • Subjects must be naïve to biologic therapy.

  • Subject must meet the following criteria for the joint assessment: • At least 6swollen joints out of 66 assessed. • At least 6 tender joints out of 68 assessed.

  • Prior Disease Modifying Antirheumatic Drug (DMARD) therapy: a) Subjects not onmethotrexate at baseline must remain without methotrexate throughout the study.Subjects on prior Methotrexate (MTX) must have discontinued at least 28 days prior toWeek 0 (Day 1). b) Subjects on Disease Modifying Antirheumatic Drug (DMARD) therapyother than Methotrexate (MTX) (except prednisone/prednisolone less than or equal to 10mg) must discontinue it for at least 28 days before the first dose of investigationalproduct at Week 0 (Day 1).

  • Female subjects are either not of childbearing potential, defined as postmenopausalfor at least 1 year or surgically sterile (bilateral tubal ligation, bilateraloophorectomy and/or hysterectomy), or are practicing at least 1 of the followingmethods of birth control throughout the study and for at least 150 days after the lastdose of study drug: • Condoms, sponge, foams, jellies, diaphragm or intrauterinedevice (IUD). • Hormonal contraceptives for 90 days prior to study drugadministration. • Vasectomized partner(s).

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

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

  • Subject has a negative Tuberculosis (TB) screening assessment (including a (PurifiedProtein Derivative (PPD) test or QuantiFERON-Tuberculosis (TB) Gold test orequivalent) and negative chest x-ray (Posterior-Anterior (PA) and lateral view) atScreening. If a subject has evidence of a latent Tuberculosis (TB) infection, thesubject 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) therapyprior to Baseline.

  • Subjects must be willing to provide written consent and to comply with therequirements of this study protocol.

Exclusion

Exclusion Criteria:

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

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

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

  • Known hypersensitivity to adalimumab or its excipients.

  • Subject currently uses or plans to use anti-retroviral therapy at any time during thestudy.

  • History of demyelinating disease (including myelitis) or neurologic symptomssuggestive of demyelinating disease.

  • History of invasive infection (e.g., listeriosis and histoplasmosis), humanimmunodeficiency syndrome (HIV).

  • Chronic recurring infections or active Tuberculosis (TB).

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

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

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

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

  • Positive pregnancy test at Screening or Baseline.

  • Subject is considered by the investigator, for any reason, to be unsuitable candidatefor the study

Study Design

Total Participants: 100
Study Start date:
June 01, 2012
Estimated Completion Date:
May 31, 2013

Connect with a study center

  • Site Reference ID/Investigator# 75100

    Brussels, 1200
    Belgium

    Site Not Available

  • Site Reference ID/Investigator# 75101

    Liege, 4000
    Belgium

    Site Not Available

  • Site Reference ID/Investigator# 75104

    Brno, 638 00
    Czech Republic

    Site Not Available

  • Site Reference ID/Investigator# 76788

    Prague 2, 128 50
    Czech Republic

    Site Not Available

  • Site Reference ID/Investigator# 75102

    Uherske Hradiste, 686 01
    Czech Republic

    Site Not Available

  • Site Reference ID/Investigator# 75103

    Zlin, 760 01
    Czech Republic

    Site Not Available

  • Site Reference ID/Investigator# 75106

    Berlin, 13125
    Germany

    Site Not Available

  • Site Reference ID/Investigator# 78014

    Ratingen, 40882
    Germany

    Site Not Available

  • Site Reference ID/Investigator# 75079

    Caguas, 00725
    Puerto Rico

    Site Not Available

  • Site Reference ID/Investigator# 75078

    Vega Baja, 00693
    Puerto Rico

    Site Not Available

  • Site Reference ID/Investigator# 76787

    Bucharest, 020475
    Romania

    Site Not Available

  • Site Reference ID/Investigator# 75978

    Cluj-Napoca, 400006
    Romania

    Site Not Available

  • Site Reference ID/Investigator# 76433

    Ploiesti, 100337
    Romania

    Site Not Available

  • Site Reference ID/Investigator# 76934

    Banska Bystrica, 97405
    Slovakia

    Site Not Available

  • Site Reference ID/Investigator# 76935

    Senica, 905 01
    Slovakia

    Site Not Available

  • Site Reference ID/Investigator# 76682

    Zilina, 010 01
    Slovakia

    Site Not Available

  • Site Reference ID/Investigator# 75073

    Mesa, Arizona 85202
    United States

    Site Not Available

  • Site Reference ID/Investigator# 75073

    Paradise Valley, Arizona 85253
    United States

    Site Not Available

  • Site Reference ID/Investigator# 75077

    Hemet, California 92543
    United States

    Site Not Available

  • Site Reference ID/Investigator# 75076

    Wichita, Kansas 67203
    United States

    Site Not Available

  • Site Reference ID/Investigator# 75075

    Clifton, New Jersey 07012
    United States

    Site Not Available

  • Site Reference ID/Investigator# 83133

    Philadelphia, Pennsylvania 19152
    United States

    Site Not Available

  • Site Reference ID/Investigator# 75074

    Charleston, South Carolina 29406
    United States

    Site Not Available

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