Study to assess pharmacokinetic, pharmacodynamic, safety and immunogenicity of a new adalimumab formulation in subjects with active rheumatoid arthritis.

Abbott GmbH & Co. KG0 sites100 target enrollmentJune 18, 2012

ConditionsRheumatoid Arthritis MedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

DrugsHumira 40 mg solution for injection in pre-filled syringe

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Abbott GmbH & Co. KG
Enrollment: 100
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 18, 2012

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Abbott GmbH & Co. KG

Eligibility Criteria

Inclusion Criteria

•1\. Male or female subject, 18 years or older who has a diagnosis of RA as defined by the 1987\-revised ACR\-classification criteria or the new ACR/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 DMARD therapy:
•a) Subjects not on methotrexate at baseline must remain without methotrexate throughout the study. Subjects on prior MTX must have discontinued at least 28 days prior to Week 0 (Day 1\).
•b) Subjects on DMARD therapy other than MTX (except prednisone/prednisolone \= 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).

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 \= 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 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 TB.
•9\. History of moderate to severe congestive heart failure (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.