N/A
N=293
Current Adoption of Composite Indices in Evaluating Rheumatoid Arthritis Patients: An Observational Study
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00793403 ↗Enrolled (actual)
293
Serious AEs
1.4%
Results posted
Feb 2013
Primary outcome: Primary: Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 6
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- As per routinary clinical care (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 6 |
— | — |
| PRIMARY Percentage of Participants With Remission as Per Modified American College of Rheumatology (Modified ACR) Criteria at Month 12 |
— | — |
| PRIMARY Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 6 |
— | — |
| PRIMARY Minimal Disease Activity: Outcome Measures in Rheumatology Arthritis Clinical Trials (OMERACT) at Month 12 |
— | — |
| PRIMARY Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 6 |
— | — |
| PRIMARY Minimal Disease Activity: Italian Group for the Study of Early Arthritis (GISEA) at Month 12 |
— | — |
| PRIMARY Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 6 |
2.80; 4.62 | — |
| PRIMARY Number of Swollen Joints (SJC) and Tender Joints (TJC) at Month 12 |
1.28; 2.35 | — |
| PRIMARY Disease Activity Score Based on 28-joints Count (DAS28) at Month 6 |
— | — |
| PRIMARY Disease Activity Score Based on 28-joints Count (DAS28) at Month 12 |
— | — |
| PRIMARY Simplified Disease Activity Index (SDAI) at Month 6 |
— | — |
| PRIMARY Simplified Disease Activity Index (SDAI) at Month 12 |
— | — |
| PRIMARY Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 6 |
3.26 | — |
| PRIMARY Rheumatoid Arthritis Disease Activity Index (RADAI) at Month 12 |
2.83 | — |
| PRIMARY Clinical Disease Activity Index (CDAI) at Month 6 |
— | — |
| PRIMARY Clinical Disease Activity Index (CDAI) at Month 12 |
— | — |
| PRIMARY Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 6 |
— | — |
| PRIMARY Patient Reported Outcomes - Clinical Arthritis Activity (PRO-CLARA ) at Month 12 |
— | — |
| PRIMARY Clinical Arthritis Activity (CLARA) Index at Month 6 |
1.79 | — |
| PRIMARY Clinical Arthritis Activity (CLARA) Index at Month 12 |
1.39 | — |
| PRIMARY Patient Global Assessment (PtGA) of Disease Activity at Month 6 |
3.71 | — |
| PRIMARY Patient Global Assessment (PtGA) of Disease Activity at Month 12 |
3.35 | — |
| PRIMARY Physician Global Assessment (PGA) of Disease Activity at Month 6 |
3.11 | — |
| PRIMARY Physician Global Assessment (PGA) of Disease Activity at Month 12 |
2.60 | — |
| PRIMARY Visual Analog Fatigue Scale (VAFS) at Month 6 |
— | — |
| PRIMARY Visual Analog Fatigue Scale (VAFS) at Month 12 |
— | — |
| PRIMARY C-reactive Protein (CRP) at Month 6 |
2.16 | — |
| PRIMARY C-reactive Protein (CRP) at Month 12 |
1.63 | — |
| PRIMARY Erythrocyte Sedimentation Rate (ESR) at Month 6 |
26.02 | — |
| PRIMARY Erythrocyte Sedimentation Rate (ESR) at Month 12 |
21.92 | — |
| PRIMARY Number of Participants With Rheumatoid Factor (RF) at Month 6 |
— | — |
| PRIMARY Number of Participants With Rheumatoid Factor (RF) at Month 12 |
— | — |
| PRIMARY Patient's General Health Assessment at Month 6 |
— | — |
| PRIMARY Patient's General Health Assessment at Month 12 |
— | — |
| PRIMARY Patient Assessment of Arthritis Pain at Month 6 |
3.58 | — |
| PRIMARY Patient Assessment of Arthritis Pain at Month 12 |
3.29 | — |
| PRIMARY Duration of Morning Stiffness at Month 6 |
— | — |
| PRIMARY Duration of Morning Stiffness at Month 12 |
— | — |
| PRIMARY Health Assessment Questionnaire (HAQ) at Month 6 |
0.83 | — |
| PRIMARY Health Assessment Questionnaire (HAQ) at Month 12 |
0.68 | — |
| PRIMARY Recent-Onset Arthritis Disability (ROAD) at Month 6 |
2.28 | — |
| PRIMARY Recent-Onset Arthritis Disability (ROAD) at Month 12 |
1.97 | — |
| PRIMARY Radiological Assessment of Hands and Feet Based on Sharp-van Der Hejde (SvH) Scoring Method at Month 6 |
— | — |
| PRIMARY Radiological Assessment of Hands and Feet Based on Sharp-Van Der Hejde (SvH) Scoring Method at Month 12 |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT00793403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.