Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment

NCT00929357 | Completed Results

• 1 other identifier: 0881X1-4617
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of Participants Without Radiographic Progression

  Baseline (Day 0) up to 48 months

• Number of Participants Without Erosions

  Baseline (Day 0) up to 48 months

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

  Baseline (Day 0) up to 48 months

• Change From Baseline in Erythrocyte Sedimentation Rate (ESR)

  Baseline (Day 0) up to 48 months

• Change From Baseline in C-reactive Protein (CRP)

  Baseline (Day 0) up to 48 months

Study Arms (2)

1

DMARDs

Drug: DMARDs or Biologics

2

Biologics

Drug: DMARDs or Biologics

Interventions

DMARDs or Biologics DRUG

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

200

You may qualify if:

• 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.

You may not qualify if:

• \- Patients who receive Anakinra, Rituximab or Abatacept

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Unknown Facility

Schmittingheide 20-32, Munster, 48155, Denmark

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Antirheumatic Agents; Biological Products

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Complex Mixtures

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 29, 2009
• Study Start: August 1, 2009
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 10, 2011
• Results First Posted: June 28, 2011

Record last verified: 2011-08

Locations

DK (1)