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The study was terminated on 10DEC2014 due to the inability to enroll the planned number of patients. There were no safety concerns.
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| adalimumab |
| ||
| Etanercept |
| ||
| infliximab |
| ||
| Certolizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-interventional study | Other | Study with 4 arms/groups with 36 patients per group. In total 144 patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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patients with Rheumatoid Arthritis (RA)
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg Universitetshospital Nord/Reumatologisk Afdelning | Aalborg | 9000 | Denmark | |||
| Aarhus Universitetshospital/Reumatologisk Afdelning U |
Not provided
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Adalimumab | Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months. |
| FG001 | Etanercept |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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Not provided
| non-interventional study | Other | Study with 4 arms/groups with 36 patients per group. In total 144 patients. |
|
| non-interventional study | Other | Study with 4 arms/groups with 36 patients per group. In total 144 patients. |
|
| non-interventional study | Other | Study with 4 arms/groups with 36 patients per group. In total 144 patients. |
|
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline, Month 3, 6, 12 |
| Aarhus C |
| 8000 |
| Denmark |
| Sydvestjysk Sygehus / Reumatologisk Afdeling | Esbjerg | 6700 | Denmark |
| Frederiksberg Hospital / Reumatologisk Afdeling | Frederiksberg | 2000 | Denmark |
| Gentofte Hospital, Medicinsk afd. C | Hellerup | 2900 | Denmark |
| Hillerod Hospital/Reumatologisk Afdeling | Hillerød | 3400 | Denmark |
| Holbaek Sygehus | Holbæk | 4300 | Denmark |
| Reumatologisk afd | Kolding | 6000 | Denmark |
| Odense Universitets Hospital/Reumatologisk Afdeling C | Odense C | 5000 | Denmark |
| Regionshospitalet Randers / Reumatologisk Klinik | Randers NØ | 8930 | Denmark |
| Svendborg Sygehus / Medicinsk Afdeling M | Svendborg | 5700 | Denmark |
| Vejle Sygehus / Medicinsk Afdeling | Vejle | 7100 | Denmark |
| Hospitalsenheden Viborg Reumatologisk Ambulatorium | Viborg | 8800 | Denmark |
Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
| FG002 | Certolizumab | Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months. |
| FG003 | Infliximab | Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Effectiveness analysis set (EAS) included all participants that provided at least 1 post-baseline assessment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Adalimumab | Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months. |
| BG001 | Etanercept | Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months. |
| BG002 | Certolizumab | Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months. |
| BG003 | Infliximab | Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Gender | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Data was not collected since this outcome measure was not analyzed due to premature termination of the study. | Posted | Month 6 |
|
| ||||||||||||||||||||||||||||
| Primary | 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. | Data was not collected since this outcome measure was not analyzed due to premature termination of the study. | Posted | Month 6 |
| |||||||||||||||||||||||||||||
| Secondary | 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. | Data was not collected since this outcome measure was not analyzed due to premature termination of the study. | Posted | Month 6, 12 |
| |||||||||||||||||||||||||||||
| Secondary | 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. | Data was not collected since this outcome measure was not analyzed due to premature termination of the study. | Posted | Month 6, 12 |
| |||||||||||||||||||||||||||||
| Secondary | 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. | Data was not collected since this outcome measure was not analyzed due to premature termination of the study. | Posted | Month 6, 12 |
| |||||||||||||||||||||||||||||
| Secondary | 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. | Data was not collected since this outcome measure was not analyzed due to premature termination of the study. | Posted | Month 3, 12 |
| |||||||||||||||||||||||||||||
| Secondary | 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. | Data was not collected since this outcome measure was not analyzed due to premature termination of the study. | Posted | Month 12 |
| |||||||||||||||||||||||||||||
| Secondary | 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. | EAS included all participants that provided at least 1 post-baseline assessment. Here,"n" signifies number of participants evaluable at the specified time points for this outcome measure. | Posted | Mean | Standard Deviation | units on a scale | Month 3, 6, 12 |
| ||||||||||||||||||||||||||
| Secondary | 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. | EAS included all participants that provided at least 1 post-baseline assessment. Here, "n" signifies number of participants evaluable for this outcome measure at the specified time points. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Month 3, 6, 12 |
|
Baseline upto 12 months
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participants may have experienced both a serious and non-serious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adalimumab | Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months. | 1 | 8 | 2 | 8 | ||
| EG001 | Etanercept | Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months. | 2 | 26 | 13 | 26 | ||
| EG002 | Certolizumab | Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months. | 2 | 36 | 6 | 36 | ||
| EG003 | Infliximab | Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months. | 0 | 9 | 6 | 9 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tuberculosis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Adenocarcinoma of esophagus | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 18.1 | Non-systematic Assessment |
| |
| Vasculitis | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Thrombopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Periumbilical pain | Gastrointestinal disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Feeling unwell | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Fever | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Therapeutic product ineffective | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Polyp | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Foreign body reaction | General disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Allergic reaction | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Allergy NOS | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cold | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Infection localised | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Nose infection NOS | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Cold sores lip | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Flu symptoms | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 18.1 | Non-systematic Assessment |
| |
| Elevated liver enzymes | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Liver function test abnormal | Investigations | MedDRA 18.1 | Non-systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Eczema aggravated | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Palmoplantar pustulosis | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Drug rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Hypertension arterial | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
| |
| Deep vein thrombosis leg | Vascular disorders | MedDRA 18.1 | Non-systematic Assessment |
|
Due to premature termination of the study, the primary objective and few of the secondary objectives for the study were not met.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Inc. | Pfizer ClinicalTrials.gov Call Center, Pfizer, Inc. | 001 800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| Male |
|
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months. |
|
| OG002 | Certolizumab | Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months. |
| OG003 | Infliximab | Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months. |
|
Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
| OG003 | Infliximab | Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months. |
|
| OG003 | Infliximab | Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months. |
|
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months. |
|
Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months. |
|
| OG002 | Certolizumab | Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months. |
| OG003 | Infliximab | Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months. |
|
|
|
| OG003 | Infliximab | Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months. |
|
|
|