Trial Outcomes & Findings for Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment (NCT NCT00929357)
NCT ID: NCT00929357
Last Updated: 2011-08-10
Results Overview
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.
COMPLETED
156 participants
Baseline (Day 0) up to 48 months
2011-08-10
Participant Flow
A total of 160 participants were screened and 156 entered this non-randomized retrospective evaluation of conventional systemic therapies and biologics in participants with rheumatoid arthritis in routine practice.
Participants had been treated according to authorized dosages for disease-modifying anti-rheumatic drug (DMARDs) and biologics in Germany. No investigational product had been provided.
Participant milestones
| Measure |
DMARDS
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
|
Biologics
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.
|
|---|---|---|
|
Overall Study
STARTED
|
92
|
64
|
|
Overall Study
COMPLETED
|
92
|
64
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retrospective Evaluation of the Radiographic Efficacy of Conventional and Biologic Treatment
Baseline characteristics by cohort
| Measure |
DMARDS
n=92 Participants
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
|
Biologics
n=64 Participants
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
|
61.6 years
STANDARD_DEVIATION 12.6 • n=39 Participants
|
58.9 years
STANDARD_DEVIATION 13.1 • n=41 Participants
|
60.5 years
STANDARD_DEVIATION 12.8 • n=35 Participants
|
|
Sex: Female, Male
Female
|
63 Participants
n=39 Participants
|
50 Participants
n=41 Participants
|
113 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=39 Participants
|
14 Participants
n=41 Participants
|
43 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) up to 48 monthsPopulation: Evaluable population: all participants who had provided two evaluable, consecutive radiographs of the hands and forefeet, taken at intervals of 12 to 48 months. Since the time period between the first and second radiograph could range between 12 to 48 months, changes in Ratingen score were to be normalized to 1 year.
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.
Outcome measures
| Measure |
DMARDS
n=92 Participants
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
|
Biologics
n=64 Participants
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.
|
|---|---|---|
|
Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression
Annualized change in Ratingen score
|
-0.1 scores on a scale
Standard Deviation 1.4
|
0.0 scores on a scale
Standard Deviation 3.3
|
|
Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression
Baseline Ratingen score - first radiograph
|
6.9 scores on a scale
Standard Deviation 10.7
|
24.3 scores on a scale
Standard Deviation 30.7
|
|
Change From Baseline in Joint Status Assessed by Radiographic (Roentgen) Progression
Change at second radiograph
|
0.0 scores on a scale
Standard Deviation 3.0
|
0.3 scores on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline (Day 0) up to 48 monthsPopulation: Evaluable population
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.
Outcome measures
| Measure |
DMARDS
n=92 Participants
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
|
Biologics
n=64 Participants
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.
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|---|---|---|
|
Number of Participants Without Radiographic Progression
|
89 participants
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59 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) up to 48 monthsPopulation: Evaluable population. Ratingen scores were calculated based on radiographic assessment, but score of 0 (no erosions) was not reported separately; data not summarized.
Radiographic assessment of no erosions using Ratingen scoring categorized as score of 0=normal joint.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (Day 0) up to 48 monthsPopulation: Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.
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.
Outcome measures
| Measure |
DMARDS
n=92 Participants
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
|
Biologics
n=64 Participants
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.
|
|---|---|---|
|
Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28)
Baseline DAS 28 - first radiograph (n=85, 61)
|
4.0 scores on a scale
Standard Deviation 1.7
|
4.0 scores on a scale
Standard Deviation 1.7
|
|
Change From Baseline in Disease Activity Score Based on 28 Joints (DAS 28)
Change at second radiograph (n=83, 58)
|
-0.8 scores on a scale
Standard Deviation 1.6
|
-0.7 scores on a scale
Standard Deviation 1.5
|
SECONDARY outcome
Timeframe: Baseline (Day 0) up to 48 monthsPopulation: Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.
Erythrocyte Sedimentation Rate measured as millimeters per hour (mm/h).
Outcome measures
| Measure |
DMARDS
n=92 Participants
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
|
Biologics
n=64 Participants
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.
|
|---|---|---|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Baseline ESR - first radiograph (n=91, 63)
|
23.8 mm/h
Standard Deviation 21.1
|
22.3 mm/h
Standard Deviation 20.5
|
|
Change From Baseline in Erythrocyte Sedimentation Rate (ESR)
Change at second radiograph (n=90, 63)
|
-3.2 mm/h
Standard Deviation 21.8
|
0.3 mm/h
Standard Deviation 19.7
|
SECONDARY outcome
Timeframe: Baseline (Day 0) up to 48 monthsPopulation: Evaluable population; (n)=number of participants with analyzable data at observation for DMARDS and Biologics, respectively.
C-reactive protein measured as milligrams per liter (mg/l)
Outcome measures
| Measure |
DMARDS
n=92 Participants
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
|
Biologics
n=64 Participants
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.
|
|---|---|---|
|
Change From Baseline in C-reactive Protein (CRP)
Baseline CRP- first radiograph (n=90, 64)
|
12.9 mg/l
Standard Deviation 20.2
|
12.9 mg/l
Standard Deviation 20.6
|
|
Change From Baseline in C-reactive Protein (CRP)
Change at second radiograph (n=89, 64)
|
-5.4 mg/l
Standard Deviation 22.6
|
-4.3 mg/l
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: Baseline (Day 0) up to 48 monthsPopulation: Evaluable population; (n)=number of participants with analyzable data at observation for Positive or Negative status for DMARDS and Biologics, respectively.
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.
Outcome measures
| Measure |
DMARDS
n=92 Participants
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
|
Biologics
n=64 Participants
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.
|
|---|---|---|
|
Number of Participants With Change From Baseline in Rheumatoid Factor (RF)
Baseline Negative RF- first radiograph
|
37 participants
|
16 participants
|
|
Number of Participants With Change From Baseline in Rheumatoid Factor (RF)
Positive RF at second radiograph (n=85, 61)
|
47 participants
|
49 participants
|
|
Number of Participants With Change From Baseline in Rheumatoid Factor (RF)
Negative RF at second radiograph
|
38 participants
|
12 participants
|
|
Number of Participants With Change From Baseline in Rheumatoid Factor (RF)
Baseline Positive RF- first radiograph (n=89, 62)
|
52 participants
|
46 participants
|
SECONDARY outcome
Timeframe: Baseline (Day 0) up to 48 monthsPopulation: Evaluable population; N=number of participants with evaluable data for CCP. CCP value as a laboratory diagnostic marker was collected within the complete timeframe and was documented only once; calculation for change in value not applicable.
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).
Outcome measures
| Measure |
DMARDS
n=85 Participants
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
|
Biologics
n=64 Participants
Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) - may be administered in combination with a conventional DMARD.
|
|---|---|---|
|
Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP)
Negative CCP
|
35 participants
|
11 participants
|
|
Number of Participants With Laboratory Result for Cyclic Citrullinated Peptide-autoantibody-test (CCP)
Positive CCP
|
50 participants
|
53 participants
|
Adverse Events
DMARDS
Biologics
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER