Formation of Antibodies and Subsequent Prediction of Clinical Response in Patients With Rheumatoid Arthritis Treated With Four TNF Blocking Agents

Pfizer79 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Rheumatoid Arthritis (RA)

Interventions

non-interventional studyOTHER

Study with 4 arms/groups with 36 patients per group. In total 144 patients.

non-interventional studyOTHER

Study with 4 arms/groups with 36 patients per group. In total 144 patients.

non-interventional studyOTHER

Study with 4 arms/groups with 36 patients per group. In total 144 patients.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject fulfils criteria for Rheumatoid Arthritis (RA) according to ACR or EULAR criteria. * Subjects who are planned to start treatment with ADA, ETA, CER or IFX * Subjects taking a minimum weekly dose of 7.5 mg of methotrexate Exclusion Criteria: * Patients with compliance problems * Patients who have difficulties in reading and understanding local language * Patients with Juvenile Idiopathic Arthritis (JIA) * Azathioprine or cyclophosphamide treatment within 6 months before entering into the study

Locations (13)

Aalborg Universitetshospital Nord/Reumatologisk Afdelning

Aalborg, Denmark

Aarhus Universitetshospital/Reumatologisk Afdelning U

Aarhus C, Denmark

Sydvestjysk Sygehus / Reumatologisk Afdeling

Esbjerg, Denmark

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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Study with 4 arms/groups with 36 patients per group. In total 144 patients.

Frederiksberg Hospital / Reumatologisk Afdeling

Frederiksberg, Denmark

Gentofte Hospital, Medicinsk afd. C

Hellerup, Denmark

Hillerod Hospital/Reumatologisk Afdeling

Hillerød, Denmark

Holbaek Sygehus

Holbæk, Denmark

Reumatologisk afd

Kolding, Denmark

Odense Universitets Hospital/Reumatologisk Afdeling C

Odense C, Denmark

Regionshospitalet Randers / Reumatologisk Klinik

Randers NØ, Denmark

...and 3 more locations

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