A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01411215
• Date of registration: 13/05/2011
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: A Study of Rheumatoid Arthritis Treatment With Enbrel in Adult Patient in Outpatient Department ENBREL NIS CN
• Scientific title: A Non-Interventional Study of the Treatment With Etanercept in Rheumatoid Arthritis (RA) and Ankylosing Spondylitis (AS) Subjects in Rheumatology Department
• Date of first enrolment: January 2011
• Target sample size: 160
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01411215
• Study type: Observational
• Phase: N/A

Countries of recruitment

China

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

- Subject has a confirmed diagnosis of rheumatoid arthritis or ankylosing spondylitis.

- Subject has accepted physician's prescription of etanercept in rheumatology
department.

- Subject agreed to be enrolled in the observational study and sign the ICD.

- Subject is=18 years of age at the time of consent.

- Subject is willing and able to understand and complete questionnaires

Exclusion Criteria:

- Presence of active or suspected latent infection including HIV, or any underlying
disease, including open cutaneous ulcers that could predispose the subject to
infections.

- Immunodeficiency syndromes including Felty syndrome or large granular lymphocyte
syndrome.

- Active tuberculosis (TB) or a history of TB, or findings consistent with previous
exposure to TB on a chest x-ray (CXR). Investigators must follow China's guidelines
for appropriate screening and treatment of TB.

- History of hypersensitivity to any of the ingredients in either preparation.



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

Health Condition(s) or Problem(s) studied

Ankylosing Spondylitis

Rheumatoid Arthritis

Intervention(s)

Drug: Enbrel

Primary Outcome(s)

Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks [Time Frame: First day of receiving etanercept through 24 weeks]

Number of Participants Who Had Any SAEs During 52 Weeks [Time Frame: Informed consent or signed data privacy statement through 52 weeks]

Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks [Time Frame: Informed consent or signed data privacy statement through 24 weeks]

Number of Participants Who Had Any AEs During 52 Weeks [Time Frame: First day of receiving etanercept through 52 weeks]

Number of Participants With AEs Per System Organ Class During 24 Weeks [Time Frame: First day of receiving etanercept through 24 weeks]

Number of Participants With AEs Per System Organ Class During 52 Weeks [Time Frame: First day of receiving etanercept through 52 weeks]

Secondary Outcome(s)

Disease Activity Score (DAS) Based on 28-joints Count and Erythrocyte Sedimentation Rate (4 Variables) (DAS28-4 [ESR]) [Time Frame: Baseline (Week 0), Week 2, Week 4, Week 12, Week 52]

Evaluate the Association Between Participant's Age and Treatment Adherence Rate [Time Frame: First day of receiving etanercept up to Week 52]

VAS Score for Pain [Time Frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52]

Number of Participants With Treatment Adherence Rate of 1), <50 Percents (%), 2), >=50% and <70%, 3), >=70% and <80%, 4), >=80% and <100%, 5), >=100% and <120%, and 6), >=120% [Time Frame: First day of receiving etanercept up to Week 52]

Number of Participants With Any Abnormal Laboratory Test Results [Time Frame: Baseline (Week 0) up to Week 52]

Physician's Global Assessment of Disease Activity [Time Frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52]

Number of RA Participants Had DAS28-4 (ESR) Improvement [Time Frame: Week 2, Week 4, Week 8, Week 12, Week 36, Week 52]

Swollen Joint Count (SJC) for RA Participants [Time Frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52]

Participant's Global Assessment (PtGA) of Disease Activity [Time Frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52]

Number of RA Participants Had Remission of Disease [Time Frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 36, Week 52]

Tender Joint Count (TJC) for RA Participants [Time Frame: Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52]

Secondary ID(s)

B1801044

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/03/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01411215