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

Information source: AbbVie
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Adalimumab, current formulation (Biological); Adalimumab, new formulation (Biological)

Phase: Phase 2

Status: Completed

Sponsored by: AbbVie (prior sponsor, Abbott)

Official(s) and/or principal investigator(s):
Andy Payne, PhD, Study Director, Affiliation: AbbVie

Summary

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

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Serum Concentrations of Adalimumab at Weeks 12 and 24

Mean Disease Activity Scores (DAS28) at Weeks 12 and 24

Secondary outcome:

Percentage of Participants With an American College of Rheumatology (ACR) 20 Response at Weeks 12 and 24

Percentage of Participants With an American College of Rheumatology (ACR) 50 Response at Weeks 12 and 24

Mean Health Assessment Questionnaire (HAQ-DI) Scores at Weeks 12 and 24

Mean Short Form-36 (SF-36) Physical Component Summary Scores and Mental Component Summary Scores at Weeks 12 and 24

Percentage of Participants Positive for Anti-adalimumab Antibody

Number of Participants With Adverse Events

Mean Injection Site Pain on a Visual Analogue Scale (VAS)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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 6

swollen joints out of 66 assessed. • At least 6 tender joints out of 68 assessed.

- Prior Disease Modifying Antirheumatic Drug (DMARD) therapy: a) 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). b) 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).

- 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).

- Subjects must be able and willing to self-administer subcutaneous (SC) injections or

have a qualified person available to administer subcutaneous (SC) injections.

- 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.

- 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.

- Subjects must be willing to provide written consent and to comply with the

requirements of this study protocol. Exclusion Criteria:

- 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.

- 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.

- 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).

- Known hypersensitivity to adalimumab or its excipients.

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

study.

- History of demyelinating disease (including myelitis) or neurologic symptoms

suggestive of demyelinating disease.

- History of invasive infection (e. g., listeriosis and histoplasmosis), human

immunodeficiency 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 condition which, in the opinion of the investigator, would put the subject at risk by participation in the protocol.

- 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.

- 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 candidate

for the study

Locations and Contacts

Site Reference ID/Investigator# 75100, Brussels 1200, Belgium

Site Reference ID/Investigator# 75101, Liege 4000, Belgium

Site Reference ID/Investigator# 75104, Brno 638 00, Czech Republic

Site Reference ID/Investigator# 76788, Prague 2 128 50, Czech Republic

Site Reference ID/Investigator# 75102, Uherske Hradiste 686 01, Czech Republic

Site Reference ID/Investigator# 75103, Zlin 760 01, Czech Republic

Site Reference ID/Investigator# 78014, Ratingen 40882, Germany

Site Reference ID/Investigator# 75079, Caguas 00725, Puerto Rico

Site Reference ID/Investigator# 75078, Vega Baja 00693, Puerto Rico

Site Reference ID/Investigator# 76787, Bucharest 020475, Romania

Site Reference ID/Investigator# 75978, Cluj-Napoca 400006, Romania

Site Reference ID/Investigator# 76433, Ploiesti 100337, Romania

Site Reference ID/Investigator# 76934, Banska Bystrica 97405, Slovakia

Site Reference ID/Investigator# 76935, Senica 905 01, Slovakia

Site Reference ID/Investigator# 76682, Zilina 010 01, Slovakia

Site Reference ID/Investigator# 75073, Mesa, Arizona 85202, United States

Site Reference ID/Investigator# 75077, Hemet, California 92543, United States

Site Reference ID/Investigator# 75076, Wichita, Kansas 67203, United States

Site Reference ID/Investigator# 75075, Clifton, New Jersey 07012, United States

Site Reference ID/Investigator# 83133, Philadelphia, Pennsylvania 19152, United States

Site Reference ID/Investigator# 75074, Charleston, South Carolina 29406, United States

Additional Information

This clinical study may be evaluating a usage that is not currently FDA-approved. Please see US prescribing information for approved uses.

Starting date: June 2012
Last updated: June 10, 2014

Page last updated: August 23, 2015

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