A Randomised, Double Blind, Placebo Controlled, Phase IIb Dose Ranging Study (With Open-label Etanercept Treatment Group) to Investigate Efficacy, Safety and Pharmacokinetics of AZD5672 Administered for 12 Weeks to Rheumatoid Arthritis Patients Receiving Methotrexate.

AstraZeneca AB,0 sites0 target enrollmentSeptember 19, 2008

Conditions-M05 M05

Overview

Phase: 未知
Intervention: Not specified
Conditions: -M05
Sponsor: AstraZeneca AB,
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 19, 2008

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Investigators

Sponsor

AstraZeneca AB,

Eligibility Criteria

Inclusion Criteria

•Provide informed consent (including consent for the PK subgroup, as applicable).
•Be male or female over 18 years of age. Note: Women with pregnancy potential can be included only if highly effective contraceptive methods are used (see Section 3\.3\.4 and Appendix K) and if patients are fully aware of the information regarding the possibility of reproductive toxicity according to it is detailed in the informed consent form. Men who participate in the study should agree to abstain from having sex for procreative purposes during the study and for 12 weeks after the last dose of study medication.
•Diagnosis of RA after 16 years of age according to the revised criteria (1987\) American Collegue of Rheumatology.
•Have active RA defined as follows: \-\> 4 swollen joints and\> 6 tender / painful joints and: ESR\> 28 mm / h or CRP\> 10 mg / L.
•Have at least one of the following items: \- Documented background of positive rheumatoid factor \- Current presence of rheumatoid factor \- Basal radiographic erosion \- Presence of anti\-citrullinated cyclic peptide antibodies (anti\-CCP) in serum.
•Oral, subcutaneous or intramuscular methotrexate for a minimum of 6 months prior to randomization. The dose and means of administration of methotrexate should have been stable between 5 mg and 25 mg per week for a minimum of 6 weeks prior to randomization.

Exclusion Criteria

•Pregnant or lactating women (restrictions and procedures related to managing the risk of pregnancy / conception for men and women are set out in Sections 3\.3\.4 and 9\.4\).
•Any systemic inflammatory affection besides RA that may interfere with the interpretation of the outcome data (among other examples we can mention polymyalgia rheumatica, gigantocellular arteritis \[including temporal], reactive arthritis).
•Current conditions with chronic pain, including fibromyalgia syndromes and chronic fatigue.
•Functional Class IV of the American College of Rheumatology or in a wheelchair / confined to the bed.
•Patients unable to comply with locally approved product information for etanercept. Note: any patient selected to receive etanercept will be confirmed as negative for LTBI prior to the start of treatment. In the event that the patient had a negative TB test in the month prior to Visit 1, the result of that analysis will prevail and the analysis should not be repeated. Patients who obtain positive results in the analysis should not continue, see Section 3\.3\.5\.1\).
•Patients who previously did not respond to treatment with more than 1 biological agent.
•Patients who, in the investigator´s opinion, have active TB as defined by clinical history and / or chest x\-ray.
•Patients who do not meet or are unlikely to comply with restrictions regarding the use of prior and concomitant medications as set forth in Section 3\.7\.
•Clinical or biochemical evidence of active infections with hepatitis B or hepatitis C (carriers may be included, ie those who have positive serology but have no evidence of active disease).
•The values of aspartate aminotransferase (AST), alanine aminotransferase (ALT) or bilirubin\> 2 x upper limit to normal (ULN) in Visit 1\.