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NCT Number: NCT00929357

Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Schmittingheide 20-32, Munster, 48155, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DMARDs or Biologics

Drug

Primary outcomes

  1. Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression

    Time frame: 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 outcomes

  1. Number of Participants Without Radiographic Progression

    Time frame: 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.

  2. Number of Participants Without Erosions

    Time frame: Baseline (Day 0) up to 48 months

    Radiographic assessment of no erosions using Ratingen scoring categorized as score of 0=normal joint.

  3. Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28)

    Time frame: 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.

  4. Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

    Time frame: Baseline (Day 0) up to 48 months

    Erythrocyte Sedimentation Rate measured as millimeters per hour (mm/h).

  5. Change From Baseline in C-reactive Protein (CRP)

    Time frame: Baseline (Day 0) up to 48 months

    C-reactive protein measured as milligrams per liter (mg/l)

  6. Number of Participants With Change From Baseline in Rheumatoid Factor (RF)

    Time frame: 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.

  7. Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 29, 2009
Registry last updated
Aug 10, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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