Evaluating Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using aSelf-Reported Questionnaire
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00121043|
Recruitment Status : Completed
First Posted : July 21, 2005
Last Update Posted : November 26, 2009
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Device: SimpleJectTM Drug: Kineret® (Anakinra)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Randomized, Crossover Study to Assess Acceptability and Functionality of SimpleJectTM Vs Pre-Filled Syringe(s) Using Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using A Self-Reported Questionnaire|
- Difference in the EAQ Part B Ease of Use Subscale Score between the two injection methods
- Difference between the two injection methods for the following
- EAQ Part B Total Score.
- EAQ Part B Overall Satisfaction Subscale Score.
- EAQ Part B Anxiety/Fear of Needles Subscale Score.
- EAQ Part B Confidence in Ability of Use Subscale Score.
- EAQ Part B Pain/Discomfort Subscale Score.
- EAQ Part C Total Preference Score.
- EAQ Quality Measures.
- EAQ Item Performance Measures.
- EAQ Instrument Reliability Measures.
- Incidence and severity of AE's.
- Incidence of concomitant medications.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00121043