N/A
N=156
Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment
Rheumatoid Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT00929357 ↗Enrolled (actual)
156
Serious AEs
0.0%
Results posted
Jun 2011
Primary outcome: Primary: Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression — 6.9; 24.3; 0.0; 0.3 scores on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- DMARDs or Biologics (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression |
6.9; 24.3; 0.0; 0.3; -0.1; 0.0 | — |
| SECONDARY Number of Participants Without Radiographic Progression |
89; 59 | — |
| SECONDARY Number of Participants Without Erosions |
— | — |
| SECONDARY Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28) |
4.0; 4.0; -0.8; -0.7 | — |
| SECONDARY Change From Baseline in Erythrocyte Sedimentation Rate (ESR) |
23.8; 22.3; -3.2; 0.3 | — |
| SECONDARY Change From Baseline in C-reactive Protein (CRP) |
12.9; 12.9; -5.4; -4.3 | — |
| SECONDARY Number of Participants With Change From Baseline in Rheumatoid Factor (RF) |
52; 46; 37; 16; 47; 49 | — |
| SECONDARY Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP) |
50; 53; 35; 11 | — |
Summary
This study involves review and analysis of disease activity in patients with rheumatoid arthritis who where treated with either conventional DMARDs (Disease Modifying Antirheumatic Drugs) or Biologics and have two existing, consecutive radiographs (x-ray images) of hand and feet taken as part of routine treatment monitoring within a time interval of 12 to 36 months.
Eligibility Criteria
Inclusion Criteria
- Secure diagnosis of rheumatoid arthritis
- Older than 18 years
- Two consecutive plain radiographs of the hands and feet with a time interval of 12 to 36 months are available. The radiographs are recorded 2003 or later and are in accordance with a defined X-ray protocol.
Exclusion Criteria
- Patients who receive Anakinra, Rituximab or Abatacept
Data sourced from ClinicalTrials.gov (NCT00929357). 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.