Current Adoption of Composite Indices in Evaluating Rheumatoid Arthritis Patients: An Observational Study
NCT00793403
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Adult Trials: 18+ Years
- 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
- Patients with tumors
- Patients already included in clinical trials
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| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title | 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") | |||
| 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. | |||
| Study Type | Observational | |||
| Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
| Target Follow-Up Duration | Not Provided | |||
| Biospecimen | Not Provided | |||
| Sampling Method | Probability Sample | |||
| Study Population | primary care clinic | |||
| Condition | Rheumatoid Arthritis | |||
| Intervention | Other: As per routinary clinical care
As per routine clinical care Other Name: Observational study | |||
| Study Groups/Cohorts | 1
As per routine clinical care Intervention: Other: As per routinary clinical care | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status | Completed | |||
| Actual Enrollment | 293 | |||
| Original Estimated Enrollment | 400 | |||
| Actual Study Completion Date | June 2010 | |||
| Actual Primary Completion Date | June 2010 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender |
| |||
| Ages | 18 Years and older (Adult, Older Adult) | |||
| Accepts Healthy Volunteers | No | |||
| Contacts | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries | Italy | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number | NCT00793403 | |||
| Other Study ID Numbers | 0881A1-102317 0881A-102317 ; B1801118 | |||
| Has Data Monitoring Committee | Yes | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement | Not Provided | |||
| Responsible Party | Pfizer | |||
| Study Sponsor | Pfizer | |||
| Collaborators | Not Provided | |||
| Investigators |
| |||
| PRS Account | Pfizer | |||
| Verification Date | December 2012 | |||