Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: DMARDs or Biologics

• Registration Number: NCT00929357
• Lead Sponsor: Pfizer

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-29
• Study Start: 2009-08
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Results First Submitted: 2011-06-06
• Results First Submitted QC: 2011-06-06
• Results First Posted: 2011-06-28
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-04
• Last Update Posted: 2011-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	DMARDs or Biologics	DMARDs
2	DMARDs or Biologics	Biologics

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression	Baseline (Day 0) up to 48 months	Radiographic progression assessed using Ratingen score with range of 0 = normal joint; 1 = one or more erosions, \<20% of the joint surface are destroyed; 2 = 21% to 40% of the joint surface are destroyed; 3 = 41% to 60% of joint surface are destroyed; 4 = 61% to 80% of the joint surface are destroyed; 5 = \>80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. Annualized change in Ratingen score calculated as (total change in Ratingen score / time period between radiograph 1 and 2 \[months\])\*12 months.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Without Radiographic Progression	Baseline (Day 0) up to 48 months	An increase of 4 or more points in the Ratingen score was necessary to detect a difference in radiographic progression. Ratingen score range 0 = normal joint to 5 = \>80% of the joint surface are destroyed. Total possible score based on 38 joints was 0 to 190; higher scores indicated greater joint destruction. A decrease of 4 (smallest detectable difference) or more points in total Ratingen score was considered a decrease in erosive damage.
Number of Participants Without Erosions	Baseline (Day 0) up to 48 months	Radiographic assessment of no erosions using Ratingen scoring categorized as score of 0=normal joint.
Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28)	Baseline (Day 0) up to 48 months	DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and patient's global assessment (PGA) of disease activity (participant rated arthritis activity assessment with transformed scores ranging 0 to 10; higher scores indicated greater affectation due to disease activity). DAS28 ≤3.2 = low disease activity, DAS28 \>3.2 to 5.1 = moderate to high disease activity.
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Baseline (Day 0) up to 48 months	Erythrocyte Sedimentation Rate measured as millimeters per hour (mm/h).
Change From Baseline in C-reactive Protein (CRP)	Baseline (Day 0) up to 48 months	C-reactive protein measured as milligrams per liter (mg/l)
Number of Participants With Change From Baseline in Rheumatoid Factor (RF)	Baseline (Day 0) up to 48 months	Rheumatoid Factor measured as a titer and categorized as negative (\<1:16 ratio) or positive. A ratio \>1:16 indicates a higher level of RF.
Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP)	Baseline (Day 0) up to 48 months	Cyclic citrullinated peptide-autoantibody-test measured as Enzyme-linked immunosorbent assay (ELISA units or EU) and categorized as negative (\<20 EU) or positive (≥20 up to \>60 EU).