Serum Biomarkers Analysis in Patients With AR Treated Wit... | NCT02804204

Studies
Serum Biomarkers Analysis in Patients With AR Treated With Anti-TMF

NCT02804204

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Status

Unknown status

Last Update Posted

Feb 7, 2019Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Rheumatoid Arthritis

Interventions

Anti-TNF

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Dec 2019Estimated

Completion Date

Dec 2019Estimated

First Submitted Date

Jun 8, 2016

First Submission Date that Met QC Criteria

Jun 14, 2016

First Posted Date

Jun 17, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2019

Last Update Posted Date

Feb 7, 2019Actual

Name	Class
UCB Pharma	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Multicenter, prospective, observational study for evaluating if circulant rheumatoid factor, cyclic citrullinated anti-peptide anti-bodies and albumin can be used as potential predictors in the response to the treatment with anti-TNF in patients with rheumatoid arthritis after 24 weeks of treatment.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Label	Type	Description	Intervention Names
Anti-TNF			Drug: Anti-TNF

Name	Type	Description	Arm Group Labels	Other Names
Anti-TNF	Drug		Anti-TNF

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Anti-TNF treatment response based on circulant rheumatoid factor		24 weeks
Anti-TNF treatment response based on circulant cyclic citrullinated anti-peptide antibodies.		24 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Both genders
Over 18 years old
Diagnosis of rheumatoid arthritis according to ACR criteria
Patients that initiate treatment with anti-TNF drugs according to clinical practice, both in naïve anti-TNF patients and patients after first anti-TNF failure
Patients able to follow the protocol requirements
Patients that signed the informed consent

Exclusion Criteria:

Patients with known hypersensitivity to investigational products
Patients with tuberculosis, or severe infections like sepsis or opportunistic infections
Patients with moderate/severe cardiac insufficiency (NHYA classification Class III/IV)
Patients that according to the investigator criteria can not participate in the study or complete the study questionnaires
Pregnant or fertile woman that does not use a contraception method

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with rheumatoid arthritis according to the ACR criteria

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sara Marsal, PhD	Contact	+34 93 402 90 82

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital San Cecilio	Not yet recruiting	Granada	Andalusia		Spain

Condition Browse Module

MeSH Terms

ID	Term
D001172	Arthritis, Rheumatoid

Ancestor Terms

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided