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

NCT01411215 | Terminated Results

• 1 other identifier: B1801044
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 15

Brief Summary

This is an open-label, multicenter and observational study in China, which is designed to record the data of RA \& AS patients within 52 weeks after rheumatologists decided to prescribe etanercept, and evaluate the safety and efficacy of the treatment. All eligible subjects agreed to be recruited in the study and can withdraw anytime if they choose so. Patients with RA or AS are typically managed by rheumatologists. As this study seeks to record the data of RA \& AS patient in etanercept and evaluate the safety and efficacy of the treatment, patients will be recruited from Rheumatic department. Rheumatologist will be asked to build up the database for RA \& AS patient surveillance prospectively in outpatient dept, which benefits for the patient treatment outcomes evaluation and clinical management.

Conditions

Rheumatoid Arthritis; Ankylosing Spondylitis

Keywords

Rheumatoid arthritis; ankylosing spondylitis; observational study

Outcome Measures

Primary Outcomes (6)

• Number of Participants Who Had Any Adverse Events (AEs) During 24 Weeks

  An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  First day of receiving etanercept through 24 weeks

• Number of Participants Who Had Any AEs During 52 Weeks

  An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

  First day of receiving etanercept through 52 weeks

• Number of Participants Who Had Any Serious Adverse Events (SAEs) During 24 Weeks

  An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Informed consent or signed data privacy statement through 24 weeks

• Number of Participants Who Had Any SAEs During 52 Weeks

  An SAE was defined as an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.

  Informed consent or signed data privacy statement through 52 weeks

• Number of Participants With AEs Per System Organ Class During 24 Weeks

  An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.

  First day of receiving etanercept through 24 weeks

• Number of Participants With AEs Per System Organ Class During 52 Weeks

  An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Participants with multiple AEs within a category (system organ class) were counted once within the category.

  First day of receiving etanercept through 52 weeks

Secondary Outcomes (11)

• Physician's Global Assessment of Disease Activity

  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

  Baseline (Week 0), Week 2, Week 4, Week 8, Week 12, Week 24, Week 36, Week 52

• VAS Score for Pain

  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%

  First day of receiving etanercept up to Week 52

• Evaluate the Association Between Participant's Age and Treatment Adherence Rate

  First day of receiving etanercept up to Week 52

Study Arms (1)

RA, AS

Rheumatoid arthritis patients Ankylosing spondylitis patients

Drug: Enbrel

Interventions

Enbrel DRUG

25mg biweekly or 50mg per week, subcutaneous injection

Also known as: etanercept

RA, AS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

outpatient RA and AS patients in China

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (15)

Daping Hospital

Chongqing, Chongqing Municipality, 400038, China

Location

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

Location

Lanzhou University Second Hospital

Lanzhou, Gansu, 730030, China

Location

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, 510405, China

Location

No. 199

Haerbin, Heilongjiang, 150001, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

The First Affiliated Hospital of Baotou Medical College

Baotou, Inner Mongolia, 014010, China

Location

Jiangsu Province Hospital/Department of Rheumatology

Nanjing, Jiangsu, 210029, China

Location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, 226001, China

Location

The Second Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Si Chuan Huaxi Hospital/Rheumatology Department

Chengdu, Sichuan, 610041, China

Location

Baotou Central Hospital

Baotou, China

Location

Shanghai Changning Guanghua Integrative Medicine Hospital

Beijing, 200052, China

Location

Shanghai Jiaotong University Affiliated Third People's Hospital

Shanghai, 201900, China

Location

Xinjiang Uygur Autonomous Region People's Hospital

Ürümqi, 830001, China

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Arthritis, Rheumatoid; Spondylitis, Ankylosing

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Ankylosis

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2011
• First Posted: August 8, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 6, 2014
• Results First Posted: March 6, 2014

Record last verified: 2014-01

Locations

CN (15)