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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 April 10, 2018

FOR MORE INFORMATION
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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Formation of Antibodies and Subsequent Prediction of Clinical Response in Patients With Rheumatoid Arthritis Treated With Four TNF Blocking Agents
Formation Of Antibodies And Subsequent Prediction Of Clinical Response In Patients With Rheumatoid Arthritis Treated With Four Tnf Blocking Agents
The 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.
no sampling
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
patients with Rheumatoid Arthritis (RA)
Rheumatoid Arthritis (RA)
Other: non-interventional study
Study with 4 arms/groups with 36 patients per group. In total 144 patients.
  • adalimumab
    Intervention: Other: non-interventional study
  • Etanercept
    Intervention: Other: non-interventional study
  • infliximab
    Intervention: Other: non-interventional study
  • Certolizumab
    Intervention: Other: non-interventional study
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
79
January 2015
January 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01691014
B1801347
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2016

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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