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
  Purpose

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.


Condition Intervention
Rheumatoid Arthritis
Drug: DMARDs or Biologics

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Evaluation of the Radiographic Efficacy of Different Conventional Systemic Therapies and Biologics in Patients With Rheumatoid Arthritis in Routine Practice.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 156
Study Start Date: August 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
DMARDs
Drug: DMARDs or Biologics
2
Biologics
Drug: DMARDs or Biologics

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

200

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929357

Locations
Denmark
Schmittingheide 20-32, Munster, Denmark, 48155
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth
ClinicalTrials.gov Identifier: NCT00929357     History of Changes
Other Study ID Numbers: 0881X1-4617
Study First Received: June 25, 2009
Results First Received: June 6, 2011
Last Updated: August 4, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 01, 2014