Clinical trial NCT00793403: Current Adoption of Composite Indices in Evaluating Rheumatoid Arthritis Patients: An Observational Study
Official title: Current Adoption Of Composite Indices In Evaluating Rheumatoid Arthritis Patients: An Observational Study ("NEW INDICES Study")
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Keywords: Observational cohort
prospectives
multicentre
the Italian study RA patient CLARA and PRO-CLARA
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-11-19
Enrollment: 293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: This is an observational study of composite indices, including the CLARA (CLinical ARthritis Activity) index, in rheumatoid arthritis (RA) patients in routine clinical practice in Italy in order to evaluate clinical remission and low disease activity. Data will be collected only from patients providing informed consent. In this study we aimed to assess the psychometric properties of a new composite instrument termed CLinical ARthritis Activity (PRO-CLARA) that uses only three PRO measures from among the 7 ACR Core Data Set. We hypothesized that this index would facilitate rapid and easy RA activity assessment in daily routine.

Detailed description: All patients who respond to inclusion/exclusion criteria at baseline will be considered valuable for the analysis.

Eligibility criteria: Inclusion Criteria:

* Eighteen years of age or older with diagnosis of RA based on the 1987 American College of Rheumatology (ACR) criteria and in accordance with local guidelines.
* Patients eligible to anti-TNF therapy
* Patients naïve to anti-TNFa drugs
* Patients with radiography (hands and feet) executed by 6 months before the baseline or at baseline according to modified Sharp Van der Hejde method \[Sharp JT et al. 1985; Sharp JT. Et al. 1989; Van der Heijde DM et al. 1989\] Patients capable of understanding and completing the questionnaire Patients capable of understanding and signing an informed consent form

Exclusion Criteria:

* Patients with tumors
* Patients already included in clinical trials

Primary outcomes:
measure: Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 6
timeFrame: Month 6
measure: Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 12
timeFrame: Month 12
measure: Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 6
timeFrame: Month 6
measure: Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 12
timeFrame: Month 12
measure: Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 6
timeFrame: Month 6
measure: Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 12
timeFrame: Month 12
measure: Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 6
timeFrame: Month 6
measure: Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 12
timeFrame: Month 12
measure: Disease Activity Score Based on 28-joints Count (DAS28) at Month 6
timeFrame: Month 6
measure: Disease Activity Score Based on 28-joints Count (DAS28) at Month 12
timeFrame: Month 12
measure: Simplified Disease Activity Index (SDAI) at Month 6
timeFrame: Month 6
measure: Simplified Disease Activity Index (SDAI) at Month 12
timeFrame: Month 12
measure: Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 6
timeFrame: Month 6
measure: Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 12
timeFrame: Month 12
measure: Clinical Disease Activity Index (CDAI) at Month 6
timeFrame: Month 6
measure: Clinical Disease Activity Index (CDAI) at Month 12
timeFrame: Month 12
measure: Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 6
timeFrame: Month 6
measure: Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 12
timeFrame: Month 12
measure: Clinical Arthritis Activity (CLARA) Index at Month 6
timeFrame: Month 6
measure: Clinical Arthritis Activity (CLARA) Index at Month 12
timeFrame: Month 12
measure: Patient Global Assessment (PtGA) of Disease Activity at Month 6
timeFrame: Month 6
measure: Patient Global Assessment (PtGA) of Disease Activity at Month 12
timeFrame: Month 12
measure: Physician Global Assessment (PGA) of Disease Activity at Month 6
timeFrame: Month 6
measure: Physician Global Assessment (PGA) of Disease Activity at Month 12
timeFrame: Month 12
measure: Visual Analog Fatigue Scale (VAFS) at Month 6
timeFrame: Month 6
measure: Visual Analog Fatigue Scale (VAFS) at Month 12
timeFrame: Month 12
measure: C-reactive Protein (CRP) at Month 6
timeFrame: Month 6
measure: C-reactive Protein (CRP) at Month 12
timeFrame: Month 12
measure: Erythrocyte Sedimentation Rate (ESR) at Month 6
timeFrame: Month 6
measure: Erythrocyte Sedimentation Rate (ESR) at Month 12
timeFrame: Month 12
measure: Number of Participants With Rheumatoid Factor (RF) at Month 6
timeFrame: Month 6
measure: Number of Participants With Rheumatoid Factor (RF) at Month 12
timeFrame: Month 12
measure: Patient's General Health Assessment at Month 6
timeFrame: Month 6
measure: Patient's General Health Assessment at Month 12
timeFrame: Month 12
measure: Patient Assessment of Arthritis Pain at Month 6
timeFrame: Month 6
measure: Patient Assessment of Arthritis Pain at Month 12
timeFrame: Month 12
measure: Duration of Morning Stiffness at Month 6
timeFrame: Month 6
measure: Duration of Morning Stiffness at Month 12
timeFrame: Month 12
measure: Health Assessment Questionnaire (HAQ) at Month 6
timeFrame: Month 6
measure: Health Assessment Questionnaire (HAQ) at Month 12
timeFrame: Month 12
measure: Recent-Onset Arthritis Disability (ROAD) at Month 6
timeFrame: Month 6
measure: Recent-Onset Arthritis Disability (ROAD) at Month 12
timeFrame: Month 12
measure: Radiological Assessment of Hands and Feet Based on Sharp-van Der Hejde (SvH) Scoring Method at Month 6
timeFrame: Month 6
measure: Radiological Assessment of Hands and Feet Based on Sharp-Van Der Hejde (SvH) Scoring Method at Month 12
timeFrame: Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Torino
country: Italy
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: