A study in Rheumatoid Arthritis patients to look at two formulations of adalimumab for pharmacokinetics and safety.
- Conditions
- Rheumatoid ArthritisMedDRA version: 14.1Level: PTClassification code 10039073Term: Rheumatoid arthritisSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disordersTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2012-000535-36-SK
- Lead Sponsor
- Abbott GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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).
• 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 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 TB screening assessment (including a PPD test or QuantiFERON-TB Gold test or equivalent) and negative chest x-ray (PA and lateral view) at Screening. If a subject has evidence of a latent TB infection, the subject must initiate and complete a minimum of 2 weeks of anti-TB therapy or have documented completion of a course of anti-TB therapy prior to Baseline.
9. Subjects must be willing to provide written consent and to comply with the requirements of this study protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
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.
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To compare the new adalimumab formulation to the currently approved (current) adalimumab formulation in a dosing regimen of 40 mg eow for 24 weeks;Secondary Objective: Not applicable;Primary end point(s): The primary end-point of the study is to compare the new formulation to the current formulation in a dosing regime of 40 mg every other week (eow).;Timepoint(s) of evaluation of this end point: 24 weeks
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Pharmacodynamic variables DAS28-CRP and American College of Rheumatology (ACR) responder rates, physical function assessed by the Health Assessment Questionnaire (HAC) and a health survey assessment using the SF-36.;Timepoint(s) of evaluation of this end point: At Week 12 and Week 24