Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment

A Retrospective Evaluation of the Radiographic Efficacy of Different Conventional Systemic Therapies and Biologics in Patients With Rheumatoid Arthritis in Routine Practice.

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: DMARDs or Biologics

• Study Type: Observational
• Enrollment (Actual): 156

Contacts and Locations

Study Locations

• Denmark
  • Munster
    • Schmittingheide 20-32, Munster, Denmark, 48155

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

200

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
1; DMARDs	Drug: DMARDs or Biologics
2; Biologics	Drug: DMARDs or Biologics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression	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.	Baseline (Day 0) up to 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Without Radiographic Progression	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.	Baseline (Day 0) up to 48 months
Number of Participants Without Erosions	Radiographic assessment of no erosions using Ratingen scoring categorized as score of 0=normal joint.	Baseline (Day 0) up to 48 months
Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28)	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.	Baseline (Day 0) up to 48 months
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)	Erythrocyte Sedimentation Rate measured as millimeters per hour (mm/h).	Baseline (Day 0) up to 48 months
Change From Baseline in C-reactive Protein (CRP)	C-reactive protein measured as milligrams per liter (mg/l)	Baseline (Day 0) up to 48 months
Number of Participants With Change From Baseline in Rheumatoid Factor (RF)	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.	Baseline (Day 0) up to 48 months
Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP)	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).	Baseline (Day 0) up to 48 months

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: June 25, 2009
• First Submitted That Met QC Criteria: June 25, 2009
• First Posted (Estimate): June 29, 2009

Study Record Updates

• Last Update Posted (Estimate): August 10, 2011
• Last Update Submitted That Met QC Criteria: August 4, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 0881X1-4617