Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00929357
First received: June 25, 2009
Last updated: August 4, 2011
Last verified: August 2011

June 25, 2009
August 4, 2011
August 2009
June 2010   (final data collection date for primary outcome measure)
Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression [ Time Frame: Baseline (Day 0) up to 48 months ] [ Designated as safety issue: No ]
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.
Retrospective assessment and comparison of the radiographic progression [ Time Frame: 12 to 36 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00929357 on ClinicalTrials.gov Archive Site
  • Number of Participants Without Radiographic Progression [ Time Frame: Baseline (Day 0) up to 48 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline (Day 0) up to 48 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Day 0) up to 48 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Day 0) up to 48 months ] [ Designated as safety issue: No ]
    Erythrocyte Sedimentation Rate measured as millimeters per hour (mm/h).
  • Change From Baseline in C-reactive Protein (CRP) [ Time Frame: Baseline (Day 0) up to 48 months ] [ Designated as safety issue: No ]
    C-reactive protein measured as milligrams per liter (mg/l)
  • Number of Participants With Change From Baseline in Rheumatoid Factor (RF) [ Time Frame: Baseline (Day 0) up to 48 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline (Day 0) up to 48 months ] [ Designated as safety issue: No ]
    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).
Number of patients without radiographic progression and number of patients without erosions [ Time Frame: 12 to 36 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

200

Rheumatoid Arthritis
Drug: DMARDs or Biologics
  • 1
    DMARDs
    Intervention: Drug: DMARDs or Biologics
  • 2
    Biologics
    Intervention: Drug: DMARDs or Biologics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
156
June 2010
June 2010   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00929357
0881X1-4617
Not Provided
Director, Clinical Trial Disclosure Group, Wyeth
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Wyeth is now a wholly owned subsidiary of Pfizer
Pfizer
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP