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

This study has been terminated.
(The study was terminated on 10DEC2014 due to the inability to enroll the planned number of patients. There were no safety concerns.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01691014
First Posted: September 24, 2012
Last Update Posted: December 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
  Purpose
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.

Condition Intervention
Rheumatoid Arthritis (RA) Other: non-interventional study

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Formation Of Antibodies And Subsequent Prediction Of Clinical Response In Patients With Rheumatoid Arthritis Treated With Four Tnf Blocking Agents

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants With Anti-drug Antibodies Formation Levels 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab [ Time Frame: Month 6 ]
    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.

  • Number of Participants With Presence of Active Drugs in Serum 6 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab [ Time Frame: Month 6 ]
    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.


Secondary Outcome Measures:
  • 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 [ Time Frame: Month 6, 12 ]
    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.

  • 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 [ Time Frame: Month 6, 12 ]
    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.

  • 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 [ Time Frame: Month 6, 12 ]
    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.

  • Number of Participants With Anti-drug Antibodies Levels 3 and 12 Months After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab [ Time Frame: Month 3, 12 ]
    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.

  • Correlation Between the Formation of Anti-drug Antibodies to Adalimumab, Certolizumab, Etanercept or Infliximab and Concomitant Methotrexate Treatment [ Time Frame: Month 12 ]
    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.

  • 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 [ Time Frame: Month 3, 6, 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.

  • Health Assessment Questionnaire (HAQ) Score After Initiation of Treatment With Adalimumab, Certolizumab, Etanercept or Infliximab at Baseline, Month 3, 6 and 12 [ Time Frame: Baseline, Month 3, 6, 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.


Enrollment: 79
Study Start Date: April 2013
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
adalimumab Other: non-interventional study
Study with 4 arms/groups with 36 patients per group. In total 144 patients.
Etanercept Other: non-interventional study
Study with 4 arms/groups with 36 patients per group. In total 144 patients.
infliximab Other: non-interventional study
Study with 4 arms/groups with 36 patients per group. In total 144 patients.
Certolizumab Other: non-interventional study
Study with 4 arms/groups with 36 patients per group. In total 144 patients.

Detailed Description:
no sampling
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with Rheumatoid Arthritis (RA)
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691014


Locations
Denmark
Aalborg Universitetshospital Nord/Reumatologisk Afdelning
Aalborg, Denmark, 9000
Aarhus Universitetshospital/Reumatologisk Afdelning U
Aarhus C., Denmark, 8000
Sydvestjysk Sygehus / Reumatologisk Afdeling
Esbjerg, Denmark, 6700
Frederiksberg Hospital / Reumatologisk Afdeling
Frederiksberg, Denmark, 2000
Gentofte Hospital, Medicinsk afd. C
Hellerup, Denmark, 2900
Hillerod Hospital/Reumatologisk Afdeling
Hillerod, Denmark, 3400
Holbaek Sygehus
Holbaek, Denmark, 4300
Reumatologisk afd
Kolding, Denmark, 6000
Odense Universitets Hospital/Reumatologisk Afdeling C
Odense C, Denmark, 5000
Regionshospitalet Randers / Reumatologisk Klinik
Randers NØ, Denmark, 8930
Svendborg Sygehus / Medicinsk Afdeling M
Svendborg, Denmark, 5700
Vejle Sygehus / Medicinsk Afdeling
Vejle, Denmark, 7100
Hospitalsenheden Viborg Reumatologisk Ambulatorium
Viborg, Denmark, 8800
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01691014     History of Changes
Other Study ID Numbers: B1801347
First Submitted: September 12, 2012
First Posted: September 24, 2012
Results First Submitted: November 1, 2016
Results First Posted: December 29, 2016
Last Update Posted: December 29, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antibodies
Immunologic Factors
Physiological Effects of Drugs