Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01557322
• Date of registration: 08/02/2012
• Prospective Registration: No
• Primary sponsor: Pfizer
• Public title: Characterize Patients With Moderately Active Rheumatoid Arthritis (RA)
• Scientific title: Evaluation of the Clinical Characteristics, Real-world Treatment Pathways, and Outcomes of Patients With Moderate Rheumatoid Arthritis
• Date of first enrolment: October 2011
• Target sample size: 1754
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01557322
• Study type: Observational
• Phase: N/A

Contacts

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

Key inclusion & exclusion criteria

Inclusion Criteria:

The Test Group will be patients with rheumatoid arthritis, newly starting therapy with
etanercept (Enbrel). Inclusion criteria for the exposed cohort subjects are:

- Patients aged 18 years and over at the time of diagnosis;

- Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and =5.1);

- Patients who have given informed consent for long term follow-up and access to all
medical records;

- Patients initiating (i.e. at leats one treatment) treatment with etanercept (Enbrel)
for RA.

The Control Group:

- Patients aged 18 years and over a the time of diagnosis;

- Patients from the BSRBR with moderate RA as defined by a DAS28 (>3.2 and =5.1);

- Patients who have given informed consent for long term follow-up and access to all
medical records; Patients are receiving at least one traditional DMARD and have never
been prescribed a biologic agent;

Exclusion Criteria:

Per BSRBR registry since data is retropsectively being analyzed



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

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Intervention(s)

Biological: etanercept

Drug: methotrexate (MTX)

Primary Outcome(s)

Change From Baseline in Tender Joints Count (TJC) at Month 60 [Time Frame: Baseline, Month 60]

Number of Participants With American College of Rheumatology (ACR) Criteria [Time Frame: Baseline]

Body Mass Index (BMI) [Time Frame: Baseline]

Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Month 60 [Time Frame: Baseline, Month 60]

Change From Baseline in Swollen Joints Count (SJC) at Month 60 [Time Frame: Baseline, Month 60]

Direct and Indirect Cost of Rheumatoid Arthritis (RA) Treatment [Time Frame: Baseline]

Number of Participants With Previous and Current Disease Modifying Anti-Rheumatic Drugs (DMARDs) [Time Frame: Baseline]

Change From Baseline in C-Reactive Protein (CRP) Level at Month 60 [Time Frame: Baseline, Month 60]

Change From Baseline in Disease Activity Score Based on 28-joints Count (DAS28) at Month 60 [Time Frame: Baseline, Month 60]

Change From Baseline in Patient's Global Assessment (PtGA) of Disease Activity at Month 60 [Time Frame: Baseline, Month 60]

Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response at Month 60 [Time Frame: Month 60]

Duration of Disease (Rheumatoid Arthritis) [Time Frame: Baseline]

Number of Participants With Chest X-Ray Prior to New Therapy [Time Frame: Baseline]

Number of Participants With Systemic Features [Time Frame: Baseline]

Time to Disease Worsening [Time Frame: Baseline up to Month 60]

Change From Baseline in 36-Item Short-Form Health Survey (SF-36) at Month 60 [Time Frame: Baseline, Month 60]

Blood Pressure (BP) [Time Frame: Baseline]

Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response at Month 60 [Time Frame: Month 60]

Change From Baseline in Euro Quality of Life - 5 Dimensions (EQ-5D) at Month 60 [Time Frame: Baseline, Month 60]

Number of Participants With Prior Joint Replacement or Surgery [Time Frame: Baseline]

Time Since First Rheumatologist Visit [Time Frame: Baseline]

Number of Participants With Comorbidities [Time Frame: Baseline]

Time Since Recalled Symptom Onset [Time Frame: Baseline]

Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Month 60 [Time Frame: Baseline, Month 60]

Time to Therapeutic Goal [Time Frame: Baseline up to Month 60]

Change From Baseline in Pain Visual Analog Scale (VAS) Score at Month 60 [Time Frame: Baseline, Month 60]

Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response at Month 60 [Time Frame: Month 60]

Number of Rheumatoid Arthritis (RA) Related Visits [Time Frame: Baseline]

Secondary ID(s)

B1801345

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/10/2013
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01557322