Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00929357
First received: June 25, 2009
Last updated: August 4, 2011
Last verified: August 2011
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| Tracking Information | |||||
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| First Received Date ICMJE | June 25, 2009 | ||||
| Last Updated Date | August 4, 2011 | ||||
| Start Date ICMJE | August 2009 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE |
Retrospective assessment and comparison of the radiographic progression [ Time Frame: 12 to 36 months ] [ Designated as safety issue: No ] | ||||
| Change History | Complete list of historical versions of study NCT00929357 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
Number of patients without radiographic progression and number of patients without erosions [ Time Frame: 12 to 36 months ] [ Designated as safety issue: No ] | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment | ||||
| Official Title ICMJE | A Retrospective Evaluation of the Radiographic Efficacy of Different Conventional Systemic Therapies and Biologics in Patients With Rheumatoid Arthritis in Routine Practice. | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | 200 |
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| Condition ICMJE | Rheumatoid Arthritis | ||||
| Intervention ICMJE | Drug: DMARDs or Biologics | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 156 | ||||
| Completion Date | June 2010 | ||||
| Primary Completion Date | June 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - Patients who receive Anakinra, Rituximab or Abatacept |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00929357 | ||||
| Other Study ID Numbers ICMJE | 0881X1-4617 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Director, Clinical Trial Disclosure Group, Wyeth | ||||
| Study Sponsor ICMJE | Pfizer | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Pfizer | ||||
| Verification Date | August 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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