An Observational, Retrospective, Multicenter, National Study for the Monitoring of Subjects Who Participated in the LoadET Clinical Trial

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01793285
• Date of registration: 30/01/2013
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: An Observational, Retrospective, Multicenter, National Study for the Monitoring of Subjects Who Participated in the LoadET Clinical Trial RELOADET
• Scientific title: Retrospective, Multicentric, National, Observational Study, to Follow-up the Patients Who Participated in the Loadet Study (RELOADET Study)
• Date of first enrolment: December 2010
• Target sample size: 85
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01793285
• Study type: Observational
• Phase: N/A

Countries of recruitment

Spain

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

- AS patients who had previously participated in the LoadET study (0881A3-102090).

- Subjects who completed the LoadET Study.

- Patients who grant their informed consent

Exclusion Criteria:

- Patients who participated in the LoadET study but who discontinued treatment and,
therefore, did not complete the study.

- Patients without standard follow-up by the physician since the end of the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Intervention(s)

Drug: ETANERCEPT

Primary Outcome(s)

Percentage of Participants Who Discontinued Treatment With Etanercept [Time Frame: Baseline up to Year 3]

Secondary Outcome(s)

Erythrocyte Sedimentation Rate (ESR) [Time Frame: Baseline, Year 1, 2, 3]

Bath Ankylosing Spondylitis Functional Index (BASFI) [Time Frame: Baseline, Year 1, 2, 3]

Fatigue as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Time Frame: Baseline, Year 1, 2, 3]

Chest Expansion Measurement [Time Frame: Baseline, Year 1, 2, 3]

Patient Global Assessment (PtGA) of Disease Activity Score [Time Frame: Baseline, Year 1, 2, 3]

Spinal Pain as Assessed Using Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Time Frame: Baseline, Year 1, 2, 3]

Time to Treatment Discontinuation With Etanercept [Time Frame: Year 3]

Occiput-to-wall Distance [Time Frame: Baseline, Year 1, 2, 3]

Time Between the Onset of Ankylosing Spondylitis Symptoms and First Visit to the Rheumatologist [Time Frame: Baseline]

C-reactive Protein (CRP) [Time Frame: Baseline, Year 1, 2, 3]

Number of Participants Who Received Non-pharmacological Treatment [Time Frame: Baseline up to Year 3]

Lipid Profile: Total Cholesterol (TC), High Density Lipoprotein (HDL) and Triglycerides Levels [Time Frame: Baseline, Year 1, 2, 3]

Modified Schober's Test [Time Frame: Baseline, Year 1, 2, 3]

Number of Participants Who Received Pharmacological Treatment [Time Frame: Baseline up to Year 3]

Time to Diagnosis of Ankylosing Spondylitis [Time Frame: Baseline]

Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Time Frame: Baseline, Year 1, 2, 3]

Secondary ID(s)

RELOADET

B1801136

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/03/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01793285