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

NCT ID: NCT01712178

Last Updated: 2014-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-05-31

Brief Summary

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

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

New formulation of adalimumab 40 mg every other week

New formulation adalimumab 40 mg every other week

Group Type: EXPERIMENTAL

Adalimumab, new formulation

Intervention Type: BIOLOGICAL

New formulation adalimumab 40 mg every other week

Current formulation adalimumab 40 mg every other week

Current formulation adalimumab 40 mg every other week

Group Type: ACTIVE_COMPARATOR

Adalimumab, current formulation

Intervention Type: BIOLOGICAL

Current formulation adalimumab 40 mg every other week

Interventions

Adalimumab, current formulation

Current formulation adalimumab 40 mg every other week

Intervention Type: BIOLOGICAL

Adalimumab, new formulation

New formulation adalimumab 40 mg every other week

Intervention Type: BIOLOGICAL

Other Intervention Names

Humira

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andy Payne, PhD

Role: STUDY_DIRECTOR

AbbVie

Locations

Site Reference ID/Investigator# 75073

Mesa, Arizona, United States

Site Reference ID/Investigator# 75077

Hemet, California, United States

Site Reference ID/Investigator# 75076

Wichita, Kansas, United States

Site Reference ID/Investigator# 75075

Clifton, New Jersey, United States

Site Reference ID/Investigator# 83133

Philadelphia, Pennsylvania, United States

Site Reference ID/Investigator# 75074

Charleston, South Carolina, United States

Site Reference ID/Investigator# 75100

Brussels, , Belgium

Site Reference ID/Investigator# 75101

Liège, , Belgium

Site Reference ID/Investigator# 75104

Brno, , Czechia

Site Reference ID/Investigator# 76788

Prague, , Czechia

Site Reference ID/Investigator# 75102

Uherské Hradiště, , Czechia

Site Reference ID/Investigator# 75103

Zlín, , Czechia

Site Reference ID/Investigator# 78014

Ratingen, , Germany

Site Reference ID/Investigator# 75079

Caguas, , Puerto Rico

Site Reference ID/Investigator# 75078

Vega Baja, , Puerto Rico

Site Reference ID/Investigator# 76787

Bucharest, , Romania

Site Reference ID/Investigator# 75978

Cluj-Napoca, , Romania

Site Reference ID/Investigator# 76433

Ploieşti, , Romania

Site Reference ID/Investigator# 76934

Banská Bystrica, , Slovakia

Site Reference ID/Investigator# 76935

Senica, , Slovakia

Site Reference ID/Investigator# 76682

Žilina, , Slovakia

Countries

United States; Belgium; Czechia; Germany; Puerto Rico; Romania; Slovakia

Related Links

http://rxabbvie.com

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

Other Identifiers

2012-000535-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M13-390

Identifier Type: -

Identifier Source: org_study_id