DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



Anakinra (Kineret®) in Combination With Disease Modifying Anti-Rheumatic Drugs (DMARDS) in Subjects With Active Rheumatoid Arthritis (RA)

Information source: Amgen
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Anakinra (Kineret®) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Amgen

Official(s) and/or principal investigator(s):
MD, Study Director, Affiliation: Amgen

Summary

The purpose of this study is to evaluate the percentage of subjects in Australian clinical practice continuing treatment with Anakinra (Kineret) at the end of study week 48 in subjects with active RA. The continued use of Kineret will be based on pre-defined response assessment criteria for subjects with active RA.

Clinical Details

Official title: An Open-Label Multicentre Study of Anakinra (Kineret) in Combination With DMARDS in Subjects With Active Rheumatoid Arthritis (RA)

Study design: Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Primary outcome: % of subjects continuing Kineret therapy at the end of the study (I.e., responders according to pre-defined response assessment criteria.)

Secondary outcome:

Change in Health Related Quality of Life (HRQOL) scores at the end of study weeks 12, 24, 36 and 48.

feasibility of simpleject device

treatment response (ACR scores, DAS 28) at the end of study weeks 12, 24, 36 and 48.

Safety of Kineret® when added to current DMARD therapy.

Eligibility

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

Criteria:

Inclusion Criteria: - Subjects diagnosed with RA as determined by American College of

Rheumatology (ACR) criteria with a disease duration of at least 24 weeks prior to

enrollment - Active RA at screening as defined by EITHER: (1) At least 6 swollen joints

(using a 66 joint count) and at least 6 tender joints (using a 68 joint count) OR (2) 4 non-hand joints and at least 1 of the following: *Morning stiffness of at least 45 minutes; *CRP greater than 1. 5 mg/dL (15. 0 mg/L); *ESR greater than 28 mm/h; *DAS28 greater than 3. 2

- Subjects must have failed an adequate trial of at least 3 disease-modifying antirheumatic

drugs (DMARDS) alone or in combination (one of which must be MTX) and have been on the same treatment and doses for 4 weeks prior to enrollment (i. e., an adequate trial is defined as

12 weeks unless limited by toxicity or intolerance) - Subjects' doses of nonsteroidal

antiinflammatory drugs (NSAIDs) and oral corticosteroids (less than or equal to 10 mg/day of prednisone or equivalent) must have been kept stable for 4 weeks prior to enrollment.

Doses of 10 mg/day prednisone or equivalent should not be exceeded during the study

Exclusion Criteria: - ACR functional class IV or ARA anatomical stage IV - Subjects that

are scheduled for surgery or being evaluated for surgery for hands, wrist and feet -

Felty's syndrome - Any poorly controlled, clinically significant systemic disease (e. g.,

chronic obstructive pulmonary disease, congestive heart failure, stroke, chronic renal

failure, liver disease) - Poorly controlled diabetes mellitus (e. g., diabetics with HbA1C

greater than 8%, peripheral neuropathy, renal/retinal involvement, or vascular disorders) -

Malignancy, other than basal cell carcinoma of the skin or in situ carcinoma of the cervix

within the past 5 years - Abnormal chest x-ray that is clinically significant or

bronchiectasis - Within 12 weeks before date of enrollment any of the following

occurrences: presence of serious infection (e. g., requiring hospitalization and/or IV

antibiotics), frequent, acute, or chronic infections - History of chronic infection -

Recent history (within 24 weeks of enrollment) of drug or alcohol abuse - Known to be

positive for hepatitis B surface antigen, hepatitis C virus, or human immunodeficiency

virus - Presence of any condition that may compromise the ability of the subject to give

informed consent - Planned events (e. g., planned hospitalizations, vacations, etc.) that

would interfere with the collection of the required assessments and/or may prevent the

subject from completing the study according to protocol - White cell count less than or

equal to 3. 5 x 10^9/L, a neutrophil count of less than or equal to 2. 5 x 10^9/L, or

platelet count of less than or equal to 125 x 10^9/L at screening - Hemoglobin less than or

equal to 8. 0 g/dL at screening - Elevated AST or ALT greater than or equal to 1. 5 x the

upper limit of normal at screening - Elevated serum creatinine greater than or equal to 1. 5

x the upper limit of normal at screening - Received intra-articular or systemic

corticosteroid injections within 4 weeks before enrollment - Subjects who have received

previous treatment with anti-IL-1ra or anti-TNF therapies (e. g., anakinra, etanercept or

infliximab) within 4 weeks prior to enrollment - Subjects who are pregnant or

breast-feeding, or plan to become pregnant during the course of the study - Subject (man or

woman) is of child bearing potential and not using adequate contraceptive precautions -

Known allergy to E. coli derived products - Receiving or has received any investigational

drug within the previous 30 days or within 5 half-lives of any investigational drug, whichever is greater (or is currently using an investigational device)

Locations and Contacts

Additional Information

AmgenTrials clinical trials website


Last updated: December 20, 2007

Page last updated: June 20, 2008

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2014