An observational study in Rheumatoid Arthritis (RA), sponsored by Pfizer. Terminated at 13 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-29.
Sponsored by Pfizer · Observational
The rationale for this study is to further explore if development of antibodies against TNF-α blocking agents is associated with reduced clinical effect/worsened clinical outcome. An important aspect of the study is to carry out an exploratory analysis of the immunogenicity of the 4 recommended TNF-α blockers in the treatment of RA in Denmark, using the same cell-based assay.
no sampling
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 79 is below the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
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patients with Rheumatoid Arthritis (RA)
Exclusion Criteria:
Other: non-interventional study
Other: non-interventional study
Other: non-interventional study
Other: non-interventional study
Study with 4 arms/groups with 36 patients per group. In total 144 patients.
Study with 4 arms/groups with 36 patients per group. In total 144 patients.
Study with 4 arms/groups with 36 patients per group. In total 144 patients.
Study with 4 arms/groups with 36 patients per group. In total 144 patients.
Number of Participants With Anti-drug Antibodies Formation Levels 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab
Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.
Time frame: Month 6
Number of Participants With Presence of Active Drugs in Serum 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab
Presence of active drugs in serum 6 months after treatment with Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.
Time frame: Month 6
Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Disease Activity Score 28 (DAS28) 12 Months After Initiation of Treatment
Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and DAS28 was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 \[good condition\] to 10 \[worst condition\]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity.
Time frame: Month 6, 12
Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Health Assessment Questionnaire (HAQ) 12 Months After Initiation of Treatment
Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and HAQ scores was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.
Time frame: Month 6, 12
Correlation Between Formation of Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab 6 Months After Initiation of Treatment and Cessation of Therapy Between Month 6 and 12 Visits
Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and cessation of therapy was to be analyzed. Cessation of therapy between month 6 and month 12 was the time to withdrawal from study due to either adverse events or lack of effect between the 6 month visit and the 12 month visit.
Time frame: Month 6, 12
Number of Participants With Anti-drug Antibodies Levels 3 and 12 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab
Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.
Time frame: Month 3, 12
Correlation Between the Formation of Anti-drug Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab and Concomitant Methotrexate Treatment
Association between formation of anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and concomitant Methotrexate treatment (weekly dose of 7.5 milligram) was to be analyzed.
Time frame: Month 12
Disease Activity Score Based on 28-Joints Count (DAS28) After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Month 3, 6 and 12
DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 \[good condition\] to 10 \[worst condition\]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS28-4 (CRP) less than or equal to (\<=) 3.2 implied low disease activity and greater than (\>) 3.2 to 5.1 implied moderate to high disease activity.
Time frame: Month 3, 6, 12
Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12
HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.
Time frame: Baseline, Month 3, 6, 12
| Milestone | Adalimumab | Etanercept | Certolizumab | Infliximab |
|---|---|---|---|---|
| Started | 8 | 26 | 36 | 9 |
| Completed | 5 | 11 | 25 | 4 |
| Not completed | 3 | 15 | 11 | 5 |
| Withdrew: Premature termination | 1 | 6 | 0 | 3 |
| Withdrew: Other | 0 | 0 | 2 | 0 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 | 1 |
| Withdrew: Adverse event | 0 | 5 | 1 | 1 |
| Withdrew: Lack of efficacy | 2 | 3 | 7 | 0 |
Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.
No measurements were reported for this outcome.
Presence of active drugs in serum 6 months after treatment with Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.
No measurements were reported for this outcome.
Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and DAS28 was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 \[good condition\] to 10 \[worst condition\]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity.
No measurements were reported for this outcome.
Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept, Infliximab and HAQ scores was to be analyzed using Pearson and Spearman correlations across and within each of the four treatment groups. HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.
No measurements were reported for this outcome.
Association between formation of antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and cessation of therapy was to be analyzed. Cessation of therapy between month 6 and month 12 was the time to withdrawal from study due to either adverse events or lack of effect between the 6 month visit and the 12 month visit.
No measurements were reported for this outcome.
Anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab were to be measured in serum samples using a validated commercially available cell-based reporter-gene assay.
No measurements were reported for this outcome.
Association between formation of anti-drug antibodies to Adalimumab, Certolizumab, Etanercept and Infliximab and concomitant Methotrexate treatment (weekly dose of 7.5 milligram) was to be analyzed.
No measurements were reported for this outcome.
DAS28-4 was calculated from swollen joint count (SJC) and tender joint count (TJC) using 28 joint count, C-reactive protein (CRP) in milligram per liter (mg/L) and participant global assessment (PGA) of disease activity (participant rated arthritis activity assessment with total score ranging from 0 \[good condition\] to 10 \[worst condition\]; higher score indicates worse condition). DAS28-4 total score range: 0 (no disease activity) to 9.4 (maximum disease activity), higher score indicates more disease activity. DAS28-4 (CRP) less than or equal to (\<=) 3.2 implied low disease activity and greater than (\>) 3.2 to 5.1 implied moderate to high disease activity.
| units on a scale | Adalimumab | Etanercept | Certolizumab | Infliximab |
|---|---|---|---|---|
| Month 3 (n= 7, 23, 34, 8) | 3.2 ± 1.0 | 3.0 ± 1.1 | 3.0 ± 1.4 | 3.0 ± 2.0 |
| Month 6 (n= 6, 18, 26, 6) | 2.7 ± 1.6 | 2.2 ± 1.1 | 2.4 ± 1.3 | 1.8 ± 1.0 |
| Month 12 (n= 5, 11, 25, 4) | 2.6 ± 0.8 | 2.4 ± 0.8 | 2.5 ± 1.1 | 2.7 ± 0.6 |
HAQ was a self-reported, valid assessment of functional disability in rheumatoid arthritis based on ability of participants to perform daily activities. HAQ total score range: 0 (normal functioning) to 3 (worst functioning), where higher score indicates worse functioning.
| units on a scale | Adalimumab | Etanercept | Certolizumab | Infliximab |
|---|---|---|---|---|
| Baseline (n= 8, 26, 36, 9) | 1.1 ± 0.6 | 1.2 ± 0.6 | 1.2 ± 0.7 | 1.1 ± 0.5 |
| Month 3 (n= 7, 23, 34, 8) | 0.8 ± 0.6 | 0.9 ± 0.7 | 0.8 ± 0.7 | 1.2 ± 0.8 |
| Month 6 (n= 6, 18, 26, 6) | 0.8 ± 0.2 | 0.6 ± 0.6 | 0.7 ± 0.6 | 0.8 ± 0.7 |
| Month 12 (n= 5, 11, 25, 4) | 0.7 ± 0.4 | 1.0 ± 0.8 | 0.6 ± 0.6 | 0.8 ± 0.7 |
Collected over Baseline upto 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Adalimumab | — | 1/8 (12.5%) | 2/8 (25%) |
| Etanercept | — | 2/26 (7.7%) | 13/26 (50%) |
| Certolizumab | — | 2/36 (5.6%) | 6/36 (16.7%) |
| Infliximab | — | 0/9 (0%) | 6/9 (66.7%) |
| Event | Adalimumab | Etanercept | Certolizumab | Infliximab |
|---|---|---|---|---|
| VasculitisVascular disorders | 1/8 | 0/26 | 0/36 | 0/9 |
| PyelonephritisInfections and infestations | 0/8 | 1/26 | 0/36 | 0/9 |
| Adenocarcinoma of esophagusNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/8 | 1/26 | 0/36 | 0/9 |
| LymphadenopathyBlood and lymphatic system disorders | 0/8 | 0/26 | 1/36 | 0/9 |
| InfectionInfections and infestations | 0/8 | 0/26 | 1/36 | 0/9 |
| TuberculosisInfections and infestations | 0/8 | 0/26 | 1/36 | 0/9 |
| Event | Adalimumab | Etanercept | Certolizumab | Infliximab |
|---|---|---|---|---|
| Urinary tract infectionInfections and infestations | 0/8 | 1/26 | 0/36 | 2/9 |
| Periumbilical painGastrointestinal disorders | 1/8 | 0/26 | 0/36 | 0/9 |
| Foreign body reactionGeneral disorders | 1/8 | 0/26 | 0/36 | 0/9 |
| Infection localisedInfections and infestations | 1/8 | 0/26 | 0/36 | 0/9 |
| Nose infection NOSInfections and infestations | 1/8 | 0/26 | 0/36 | 0/9 |
| Hypertension arterialVascular disorders | 1/8 | 0/26 | 0/36 | 0/9 |
| NauseaGastrointestinal disorders | 0/8 | 0/26 | 1/36 | 1/9 |
| Feeling unwellGeneral disorders | 0/8 | 0/26 | 0/36 | 1/9 |
| PolypGeneral disorders | 0/8 | 0/26 | 0/36 | 1/9 |
| Allergy NOSImmune system disorders | 0/8 | 0/26 | 0/36 | 1/9 |
Effectiveness analysis set (EAS) included all participants that provided at least 1 post-baseline assessment.
| Age, Continuous(years) | Adalimumab | Etanercept | Certolizumab | Infliximab | Total |
|---|---|---|---|---|---|
| Mean | 51 ± 6 | 57 ± 13 | 56 ± 14 | 51 ± 11 | 55 ± 13 |
| Gender(Participants) | Adalimumab | Etanercept | Certolizumab | Infliximab | Total |
|---|---|---|---|---|---|
| Female | 4 | 21 | 23 | 6 | 54 |
| Male | 4 | 5 | 13 | 3 | 25 |
This study is terminated, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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