The study was terminated on 10DEC2014 due to the inability to enroll the planned number of patients. There were no safety concerns.
Formation Of Antibodies And Subsequent Prediction Of Clinical Response In Patients With Rheumatoid Arthritis Treated With Four Tnf Blocking Agents
Sponsor study identifier
observational
79
1 country
13
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 12, 2012
Actual (reported)September 24, 2012
Actual (reported)April 2013
Date type not reportedThis date has not been verified as actual or estimated.
January 2015
Actual (reported)January 2015
Actual (reported)December 29, 2016
Actual (reported)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
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
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
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
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
Month 3, 12
Correlation Between the Formation of Anti-drug Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab and Concomitant Methotrexate Treatment
Month 12
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.
patients with Rheumatoid Arthritis (RA)
Aalborg Universitetshospital Nord/Reumatologisk Afdelning
Aalborg, 9000, Denmark
Aarhus Universitetshospital/Reumatologisk Afdelning U
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
Due to premature termination of the study, the primary objective and few of the secondary objectives for the study were not met.
Pfizer CT.gov Call Center
Pfizer
79 participants (actual enrollment reported by the registry).
First Submitted
September 12, 2012
First Posted
September 24, 2012
Study Start
April 2013
Date type not reportedThis date has not been verified as actual or estimated.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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
Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
December 29, 2016
Results First Posted
December 29, 2016
Record last verified: 2016-11
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Source: ClinicalTrials.gov.
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