Rheumatoid ArthritisANTIBODY-RANCT01981473
Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or Infliximab
An observational study of Rheumatoid Arthritis, run by Pfizer at 54 sites in 5 countries.
Trial summary
The purpose of this study is to examine the relationship between anti-drug antibodies, serum drug concentrations, and clinical response for rheumatoid arthritis patients being treated with etanercept, adalimumab or infliximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 605 participants
- Where
- 54 sitesin 5 countries
- Study dates
- Jan 2014to Dec 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population will be selected from patients seen in a rheumatology clinical setting who currently treated with etanercept, adalimumab or infliximab for rheumatoid arthritis
Who may be able to join
- Age 18 years or older.
- Diagnosis of RA based on the 1987 American College of Rheumatology revised criteria
- Current continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months and maximum of 24 months.
Who cannot join
- Treatment with biosimilar or investigational etanercept, adalimumab, or infliximab within past 6 months.
- Treatment with any other investigational drugs within past 3 months or five half lives of the drug, whichever is longer.
- Any medical condition that would interfere with rheumatoid arthritis evaluation or other study assessments (eg, fibromyalgia, lupus).
Trial locations and contacts
54 sites in 5 countries.
54 sites in 5 countries
United States34 sites
Austin Regional Clinic
Austin, Texas, 78731
Rheumatology Associates of Baltimore
Baltimore, Maryland, 21286
Advanced Arthritis Care Center
Brooklyn, New York, 11235
Box Arthritis and Rheumatology
Charlotte, North Carolina, 28210
Center for Arthritis and Rheumatic Diseases, P.C.
Chesapeake, Virginia, 23320
Omega Research Consultants, LLC
DeBary, Florida, 32713
Phase III Clinical Research
Fall River, Massachusetts, 02720
David S. Rosenberg, M.D
Florissant, Missouri, 63031
Center for Rheumatology, Immunology, and Arthritis
Fort Lauderdale, Florida, 33309
Florida Medical Research
Gainesville, Florida, 32607
Northeast Georgia Diagnostic Clinic, LLC
Gainesville, Georgia, 30501
Arizona Arthritis & Rheumatology
Glendale, Arizona, 85304
Comprehensive Rheumatology Care
Hendersonville, Tennessee, 37075
Elizabeth Marini Simpson
Hixon, Tennessee, 37343
Mercy Clinic Hot Springs Communities
Hot Springs, Arkansas, 71913
Accurate Clinical Research
Houston, Texas, 77084
Clinical Research Institute of Houston
Houston, Texas, 77090
Rheumatology Consultants of Delaware dba Delaware Arthritis
Lewes, Delaware, 19958
Dr Melvin Albert Churchill Jr
Lincoln, Nebraska, 68516
Arizona Arthritis & Rheumatology Associates, P. C.
Mesa, Arizona, 85202
Prospect Medical Offices
Midland Park, New Jersey, 07432
Low Country Rheumatology, PA
North Charleston, South Carolina, 29406
Arizona Arthritis & Rheumatology
Phoenix, Arizona, 85032
Arizona Arthritis and Rheumatology Research, PLLC
Phoenix, Arizona, 85032
Prem C.Chatpar, M.D., LLC
Plainview, New York, 11803
Sutter Institute for Medical Research
Sacramento, California, 95816
Arthritis Care Center, Incorporated
San Jose, California, 95035
Arthritis and Rheumatic Care Center
South Miami, Florida, 33143
Arthritis Northwest, PLLC
Spokane, Washington, 99204
Arizona Arthritis & Rheumatology Research
Sun City, Arizona, 85351
Health Point Medical Group, Inc.
Tampa, Florida, 33614
Spring Clinical Research
Tomball, Texas, 77375
Via Christi Hospitals Wichita, Inc.
Wichita, Kansas, 67214
Clinical Research Center of Reading, LLC
Wyomissing, Pennsylvania, 19610
Argentina11 sites
Hospital Británico de Buenos Aires
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1280AEB
Sociedad Italiana de Beneficencia en Buenos Aires (Hospital Italiano de Buenos Aires)
Ciudad Autónoma de Buenos Aires / Buenos Aires, Buenos Aires / Argentina, C1181ACH
Clínica Adventista Belgrano
Ciudad Autónoma de Buenos Aires / Buenos Aires, Ciudad Autónoma de Buenos Aires / Buenos Aires /Argentina., C1430EGF
CIER, centro de investigaciones en enfermedades reumáticas (Razón social: ARIES MEDICA S.R.L.)
Ciudad de Buenos Aires / Buenos Aires, Ciudad de Buenos Aires, Buenos Aires, Argentina, C1055AAF
Sociedad Española de Beneficiencia y Mutualidad Hospital español de Mendoza
Godoy Cruz, Mendoza / Argentina, M5501AAJ
DIM Clinica Privada
Ramos Mejía, Ramos Mejía / Buenos Aires / Argentina, B1704ETD
Instituto CAICI SRL.
Rosario, Santa Fe / Argentina, S2000PBJ
Centro Integral de Reumatología S.R.L.
S.M. de Tucumán / Tucumán, S.M. de Tucumán / Tucumán / Argentina., 4000
Instituto de Asistencia Reumatológica Integral I.A.R.I
San Fernando, Buenos Aires / Argentina, 1646
C.E.R - Centro Polivalente de Asistencia e Investigación Clínica propiedad de CER SAN JUAN S.R.L.
San Juan, San Juan / San Juan / Buenos Aires, J5402DIL
I.N.Ne.L S.R.L. (Instituto de Neurología y Neurorrehabilitación del Litoral S.R.L.)
Santa Fe, Santa Fé / Argentina, S3000ASL
Bulgaria4 sites
MHAT Burgas
Burgas, 8000
DCC Sveti Pantaleimon OOD
Pleven, 5800
MHAT Kaspela EOOD
Plovdiv, 4000
UMHAT "Sv.Ivan Rilski"
Sofia, 1612
Turkey (Türkiye)4 sites
Cukurova Universitesi Tip Fakultesi Balcalı Hastanesi
Adana, 01030
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, 06100
Ataturk Universitesi Yakutiye Egitim ve Arastirma Hastanesi
Erzurum, 25240
Osmangazi Universitesi Tıp Fakultesi Hastanesi
Eskişehir, 26480
Australia1 site
Southern Clinical Research Pty Ltd
Sandy Bay, Hobart, Tasmania, 7000
About this study
Official title: Anti-tnf Inhibitor Antibody-mediated Blockade Of Drug Efficacy In Rheumatoid Arthritis (Antibody-ra)
The purpose of this study is to examine the relationship between anti-drug antibodies, serum drug concentrations, and clinical response for rheumatoid arthritis patients being treated with etanercept, adalimumab or infliximab.
Read the detailed description
cross-sectional Population will be selected through convenience sampling. Patients sequentially visiting the rheumatology clinic for routine care who are receiving etanercept, adalimumab, or infliximab for between 6 and 24 months will be evaluated for eligibility and interest in participation. A maximum of 200 patients per treatment will be enrolled.
- Conditions
- Rheumatoid Arthritis
- Being tested
- no intervention
- Keywords
- rheumatoid arthritis, etanercept, adalimumab, infliximab, anti-drug antibody, immunogenicity, drug concentration
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
Also called Enbrel
no interventionOther
Also called Humira
no interventionOther
Also called Remicade
| Study group | Role | What they receive |
|---|---|---|
| etanercept | Participants currently receiving etanercept treatment in a clinical setting for a minimum of 6 months and maximum of 24 months prior to study assessment visit. Receives: Other: no intervention | |
| adalimumab | Participants currently receiving adalimumab treatment in a clinical setting for a minimum of 6 months and maximum of 24 months prior to study assessment visit. Receives: Other: no intervention | |
| infliximab | Participants currently receiving infliximab treatment in a clinical setting for a minimum of 6 months and maximum of 24 months prior to study assessment visit. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab).
Percentage of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab) was determined.
Measured: 1 day
Secondary outcomes (11)
Percentage of Participants With Low Disease Activity (LDA) (DAS28 ESR Score ≤ 3.2) Among Those Who Are Antidrug Antibody Positive Versus Negative (All Patients Receiving Etanercept, Adalimumab, or Infliximab Combined).
Percentage of participants with Low Disease Activity (LDA) (Disease Activity Score based on a 28-joint count [DAS28] Erythrocyte sedimentation rate [ESR] score ≤3.2) among those who are antidrug antibody positive versus negative (all participants receiving etanercept, adalimumab, or infliximab combined).
Measured: 1 day
Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Serum trough drug concentrations for etanercept, adalimumab, and infliximab compared between participants who are antidrug antibody positive versus negative. Units of measurement for Serum trough drug concentration is µg/mL.
Measured: 1 day
Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab.
Percentage of participants positive for antidrug antibodies among those treated with etanercept, adalimumab, or infliximab were determined.
Measured: 1 Day
The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
The CDAI total scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. CDAI = Disease activity score (DAS) 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician's Global Assessment (0-10) + Subject's Global Assessment (0-10). The total score range is 0-76. Score interpretation: Remission ≤ 2.8; Low Disease Activity CDAI > 2.8 and ≤ 10; Moderate Disease Activity CDAI > 10 and ≤ 22; High Disease Activity CDAI > 22.
Measured: 1 Day
The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
The SDAI Total Scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative. SDAI = DAS 28 prorated Swollen Joint Count (0-28) + DAS 28 prorated Tender Joint Count (0-28) + Physician's Global Assessment (0-10) + Subject's Global Assessment (0-10) + C-reactive protein (CRP) (in mg/dL). The total score range is 0-86. Score interpretation: Remission SDAI ≤ 3.3; Low Disease Activity SDAI > 3.3 and ≤ 11; Moderate Disease Activity SDAI > 11 and ≤ 26; High Disease Activity SDAI > 26.
Measured: 1 day
Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0-100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0- 100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject's General Health VAS assessment.
Measured: 1 day
Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
The DAS28 assessment is a derived measurement with differential weight given to each component. DAS28 will be calculated twice, utilizing first ESR, and then CRP as the acute phase reactant: 1) DAS28-ESR = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen joint count) + 0.70 (ln ESR) + 0.014 GH, where GH=subject general health VAS (0 100 mm). 2) DAS28-4 CRP = 0.56 sqrt (28 painful/tender joint count) + 0.28 sqrt (28 swollen count) + 0.36 (ln CRP+1) + 0.014 GH + 0.96, where GH=subject general health VAS (0-100 mm), higher scores were indicative of a worse outcome. The specific components of the DAS28 assessment that were used in this study are: Tender/Painful Joint Count (28), Swollen Joint Count (28), ESR/CRP, and Subject's General Health VAS assessment.
Measured: 1 day
Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
The HAQ-DI assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items. For each question in the questionnaire, the level of difficulty is scored from 0 to 3 with 0 representing "no difficulty," 1 as "some difficulty," 2 as "much difficulty," and 3 as "unable to do." Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status. The total score range for the HAQ-DI scale, minimum score was 0 (best), maximum score was 3 (worst).
Measured: 1 day
Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
HAQ DI (<=0.5) scores for etanercept, adalimumab, or infliximab compared between participants who are antidrug antibody positive versus negative.
Measured: 1 day
Correlation of Antidrug Antibody Titers With Efficacy Measures.
Correlation of antidrug antibody titers with efficacy measures analysed using Spearman correlation coefficient.
Measured: 1 day
Correlation of Antidrug Antibody Titers With Trough Drug Concentration.
Correlation of antidrug antibody titers with trough drug concentration analysed using Spearman correlation coefficient.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 605 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01981473
- Sponsor's protocol ID
- B1801364
- Other IDs
- ANTIBODY-RA
- Acronym
- ANTIBODY-RA
- Status last verified
- Dec 2015
- First submitted
- 5 Nov 2013
- Last updated
- 12 Jan 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Bassiouni H, Spargo CE, Vlahos B, Jones HE, Pedersen R, Shirazy K. Maintenance of Remission with Etanercept-DMARD Combination Therapy Compared with DMARDs Alone in African and Middle Eastern Patients with Active Rheumatoid Arthritis. Rheumatol Ther. 2018 Jun;5(1):149-158. doi: 10.1007/s40744-018-0094-6. Epub 2018 Feb 26.
PubMed 29480357
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-tnf Inhibitor Antibody-mediated Blockade Of Drug Efficacy In Rheumatoid Arthritis (Antibody-ra)
- ClinicalTrials.gov ID
- NCT01981473
- Acronym / sponsor ID
- ANTIBODY-RA / B1801364
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, etanercept, adalimumab, infliximab, anti-drug antibody, immunogenicity, drug concentration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 605 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 11 Nov 2013 (estimated)
- Results
- Posted 12 Jan 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the relationship between anti-drug antibodies, serum drug concentrations, and clinical response for rheumatoid arthritis patients being treated with etanercept, adalimumab or infliximab.
Detailed description
cross-sectional Population will be selected through convenience sampling. Patients sequentially visiting the rheumatology clinic for routine care who are receiving etanercept, adalimumab, or infliximab for between 6 and 24 months will be evaluated for eligibility and interest in participation. A maximum of 200 patients per treatment will be enrolled.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| etanercept | – | Other: no interventionParticipants currently receiving etanercept treatment in a clinical setting for a minimum of 6 months and maximum of 24 months prior to study assessment visit. |
| adalimumab | – | Other: no interventionParticipants currently receiving adalimumab treatment in a clinical setting for a minimum of 6 months and maximum of 24 months prior to study assessment visit. |
| infliximab | – | Other: no interventionParticipants currently receiving infliximab treatment in a clinical setting for a minimum of 6 months and maximum of 24 months prior to study assessment visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population will be selected from patients seen in a rheumatology clinical setting who currently treated with etanercept, adalimumab or infliximab for rheumatoid arthritis
Key inclusion criteria (3 listed)
- Age 18 years or older.
- Diagnosis of RA based on the 1987 American College of Rheumatology revised criteria
- Current continuous treatment with either etanercept, adalimumab, or infliximab for a minimum of 6 months and maximum of 24 months.
Key exclusion criteria (3 listed)
- Treatment with biosimilar or investigational etanercept, adalimumab, or infliximab within past 6 months.
- Treatment with any other investigational drugs within past 3 months or five half lives of the drug, whichever is longer.
- Any medical condition that would interfere with rheumatoid arthritis evaluation or other study assessments (eg, fibromyalgia, lupus).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionAlso: Enbrel | Other | etanercept |
| no interventionAlso: Humira | Other | adalimumab |
| no interventionAlso: Remicade | Other | infliximab |
Primary outcome
Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab).
Time frame: 1 day
Percentage of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab) was determined.
11 secondary outcomes
Percentage of Participants With Low Disease Activity (LDA) (DAS28 ESR Score ≤ 3.2) Among Those Who Are Antidrug Antibody Positive Versus Negative (All Patients Receiving Etanercept, Adalimumab, or Infliximab Combined).
Time frame: 1 day
Serum Trough Drug Concentrations for Etanercept, Adalimumab, and Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Time frame: 1 day
Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept, Adalimumab, or Infliximab.
Time frame: 1 Day
The Clinical Disease Activity Index (CDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Time frame: 1 Day
The Simplified Disease Activity Index (SDAI) Total Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Time frame: 1 day
Disease Activity Score Based on a 28-joint Count (DAS28), Calculated With Erythrocyte Sedimentation Rate for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Time frame: 1 day
Disease Activity Score, 28 Joint Count, Calculated With C-reactive Protein (DAS28-CRP) for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Time frame: 1 day
Health Assessment Questionnaire-Disability Index (HAQ DI) Scores for for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Time frame: 1 day
Percentage of HAQ DI (<=0.5) Scores for Etanercept, Adalimumab, or Infliximab Compared Between Participants Who Are Antidrug Antibody Positive Versus Negative.
Time frame: 1 day
Correlation of Antidrug Antibody Titers With Efficacy Measures.
Time frame: 1 day
Correlation of Antidrug Antibody Titers With Trough Drug Concentration.
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29480357Bassiouni H, Spargo CE, Vlahos B, Jones HE, Pedersen R, Shirazy K. Maintenance of Remission with Etanercept-DMARD Combination Therapy Compared with DMARDs Alone in African and Middle Eastern Patients with Active Rheumatoid Arthritis. Rheumatol Ther. 2018 Jun;5(1):149-158. doi: 10.1007/s40744-018-0094-6. Epub 2018 Feb 26.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
54 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Pfizer at 54 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 54 sites in United States, Argentina, Bulgaria, Turkey (Türkiye), Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Positive for Antidrug Antibodies Among Those Treated With Etanercept Versus Those Treated With Monoclonal Antibodies (Adalimumab or Infliximab). (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01981473, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.