Evaluating Kineret® (Anakinra) in Rheumatoid Arthritis (RA) Subjects Using aSelf-Reported Questionnaire
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ClinicalTrials.gov Identifier: NCT00121043 |
Recruitment Status :
Completed
First Posted : July 21, 2005
Last Update Posted : November 26, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Device: SimpleJectTM Drug: Kineret® (Anakinra) | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |

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
Study Director: | MD | Amgen |
Additional Information:
Responsible Party: | Global Development Leader, Amgen Inc. |
ClinicalTrials.gov Identifier: | NCT00121043 History of Changes |
Other Study ID Numbers: |
20020125 |
First Posted: | July 21, 2005 Key Record Dates |
Last Update Posted: | November 26, 2009 |
Last Verified: | December 2007 |
Keywords provided by Swedish Orphan Biovitrum:
Rheumatoid Arthritis, Inflammation Interleukin-1 (IL-1), r-metHuIL-1ra Autoimmune, Kineret® Anakinra, Immunex Amgen, Clinical Trials |
Additional relevant MeSH terms:
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |
Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Interleukin 1 Receptor Antagonist Protein Antirheumatic Agents |