Clinical trial NCT01691014: Formation of Antibodies and Subsequent Prediction of Clinical Response in Patients With Rheumatoid Arthritis Treated With Four TNF Blocking Agents
Official title: Formation Of Antibodies And Subsequent Prediction Of Clinical Response In Patients With Rheumatoid Arthritis Treated With Four Tnf Blocking Agents
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Rheumatoid Arthritis (RA)
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-09-24
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Rheumatoid Arthritis (RA)

Brief summary: 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.

Detailed description: no sampling

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Anti-drug Antibodies Formation Levels 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab
timeFrame: Month 6
measure: Number of Participants With Presence of Active Drugs in Serum 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab
timeFrame: Month 6
Secondary outcomes:
measure: 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
timeFrame: Month 6, 12
measure: 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
timeFrame: Month 6, 12
measure: 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
timeFrame: Month 6, 12
measure: Number of Participants With Anti-drug Antibodies Levels 3 and 12 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab
timeFrame: Month 3, 12
measure: Correlation Between the Formation of Anti-drug Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab and Concomitant Methotrexate Treatment
timeFrame: Month 12
measure: 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
timeFrame: Month 3, 6, 12
measure: Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12
timeFrame: Baseline, Month 3, 6, 12
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital Nord/Reumatologisk Afdelning
city: Aarhus C.
country: Denmark
facility: Aarhus Universitetshospital/Reumatologisk Afdelning U
city: Esbjerg
country: Denmark
facility: Sydvestjysk Sygehus / Reumatologisk Afdeling
city: Frederiksberg
country: Denmark
facility: Frederiksberg Hospital / Reumatologisk Afdeling
city: Hellerup
country: Denmark
facility: Gentofte Hospital, Medicinsk afd. C
city: Hillerod
country: Denmark
facility: Hillerod Hospital/Reumatologisk Afdeling
city: Holbaek
country: Denmark
facility: Holbaek Sygehus
city: Kolding
country: Denmark
facility: Reumatologisk afd
city: Odense C
country: Denmark
facility: Odense Universitets Hospital/Reumatologisk Afdeling C
city: Randers NØ
country: Denmark
facility: Regionshospitalet Randers / Reumatologisk Klinik
city: Svendborg
country: Denmark
facility: Svendborg Sygehus / Medicinsk Afdeling M
city: Vejle
country: Denmark
facility: Vejle Sygehus / Medicinsk Afdeling
city: Viborg
country: Denmark
facility: Hospitalsenheden Viborg Reumatologisk Ambulatorium
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: