Formation of Antibodies and Subsequent Prediction of Clinical Response in Patients With Rheumatoid Arthritis Treated With Four TNF Blocking Agents
This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01691014
First received: September 12, 2012
Last updated: May 14, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 | Phase |
|---|---|---|
|
Rheumatoid Arthritis (RA) |
Other: non-interventional study |
Phase 4 |
| 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:
- Anti-drug antibody levels and serum levels of active drug 6 months after initiation of treatment with adalimumab (ADL), certolizumab (CER), etanercept (ETA) or infliximab (IFX). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Description of the association between the formation of antibodies to ADL, CER, ETA and IFX 6 months after initiation of treatment with ADL, CER, ETA or IFX and the clinical response 12 months after initiation of treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Anti-drug antibody levels 3 and 12 months after initiation of treatment with ADL, CER, ETA or IFX [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
- Description of the association between the formation of anti-drug antibodies and concomitant methotrexate (MTX) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- DAS 28 3, 6 and 12 months after initiation of treatment with ADL, CER, ETA or IFX. [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
- HAQ score at baseline, 3, 6 and 12 months after initiation of treatment with ADL, CER, ETA or IFX. [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 144 |
| Study Start Date: | March 2013 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | February 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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01691014
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Locations
| Denmark | |
| Pfizer Investigational Site | Recruiting |
| Aalborg, Denmark, 9000 | |
| Pfizer Investigational Site | Recruiting |
| Aarhus C., Denmark, 8000 | |
| Pfizer Investigational Site | Recruiting |
| Hellerup, Denmark, 2900 | |
| Pfizer Investigational Site | Not yet recruiting |
| Hillerod, Denmark, 3400 | |
| Pfizer Investigational Site | Recruiting |
| Kolding, Denmark, 6000 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01691014 History of Changes |
| Other Study ID Numbers: | B1801347 |
| Study First Received: | September 12, 2012 |
| Last Updated: | May 14, 2013 |
| Health Authority: | Denmark: Ethics Committee |
Additional relevant MeSH terms:
|
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 23, 2013