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

Last updated on November 12, 2019

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Study Location
Aalborg Universitetshospital Nord/Reumatologisk Afdelning
Aalborg, , 9000 Denmark
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis (RA)
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT01691014
Pfizer
Terminated
Formation of Antibodies and Subsequent Prediction of Clinical Response in Patients With Rheumatoid Arthritis Treated With Four TNF Blocking Agents

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Descriptive Information
Brief TitleFormation of Antibodies and Subsequent Prediction of Clinical Response in Patients With Rheumatoid Arthritis Treated With Four TNF Blocking Agents
Official TitleFormation Of Antibodies And Subsequent Prediction Of Clinical Response In Patients With Rheumatoid Arthritis Treated With Four Tnf Blocking Agents
Brief SummaryThe rationale for this study is to further explore if development of antibodies against TNF-? 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-? blockers in the treatment of RA in Denmark, using the same cell-based assay.
Detailed Descriptionno sampling
Study TypeObservational
Study DesignObservational Model: Cohort
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study Populationpatients with Rheumatoid Arthritis (RA)
ConditionRheumatoid Arthritis (RA)
InterventionOther: non-interventional study
Study with 4 arms/groups with 36 patients per group. In total 144 patients.
Study Groups/Cohorts
  • adalimumab
    Intervention: Other: non-interventional study
  • Etanercept
    Intervention: Other: non-interventional study
  • infliximab
    Intervention: Other: non-interventional study
  • Certolizumab
    Intervention: Other: non-interventional study
Publications *Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment StatusTerminated
Actual Enrollment
 (submitted: November 1, 2016)
79
Original Estimated Enrollment
 (submitted: September 21, 2012)
144
Actual Study Completion DateJanuary 2015
Actual Primary Completion DateJanuary 2015   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesDenmark
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01691014
Other Study ID NumbersB1801347
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateNovember 2016

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