Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment

• ClinicalTrials.gov Identifier: NCT00929357
• Recruitment Status: Completed
• First Posted: June 29, 2009
• Results First Posted: June 28, 2011
• Last Update Posted: August 10, 2011
• Sponsor: Pfizer
• Information provided by: Pfizer

Study Description

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.

Condition or disease	Intervention/treatment
Rheumatoid Arthritis	Drug: DMARDs or Biologics

Study Design

• Study Type: Observational
• Actual Enrollment: 156 participants
• 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.
• Study Start Date: August 2009
• Actual Primary Completion Date: June 2010
• Actual Study Completion Date: June 2010

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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).

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: Director, Clinical Trial Disclosure Group, Wyeth
• ClinicalTrials.gov Identifier: NCT00929357
• Other Study ID Numbers: 0881X1-4617
• First Posted: June 29, 2009
• Results First Posted: June 28, 2011
• Last Update Posted: August 10, 2011
• Last Verified: August 2011

Additional relevant MeSH terms:

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