Biomarkers Identification of Anti-tumor Necrosis Factor (... | NCT02492217

Studies
Biomarkers Identification of Anti-tumor Necrosis Factor (TNF) α Agent's Efficacy in Ankylosing Spondylitis Patients

NCT02492217

Sponsor

Universidade Nova de Lisboa

Status

Completed

Last Update Posted

Nov 3, 2020Actual

Enrollment

69Actual

Phase

Phase 4

Conditions

Ankylosing Spondylitis

Interventions

Adalimumab

Countries

Portugal

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

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015Actual

Primary Completion Date

May 2018Actual

Completion Date

May 28, 2018Actual

First Submitted Date

Jul 3, 2015

First Submission Date that Met QC Criteria

Jul 7, 2015

First Posted Date

Jul 8, 2015Estimated

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

Oct 30, 2020

Last Update Posted Date

Nov 3, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

To identify new candidate genes and proteins that are differentially expressed in responders' vs non-responders to anti-TNF alpha therapy at the several time points the investigators will use the transcriptomic and proteomic analyses. Demonstrate a link between gene expression and protein markers regarding prediction to anti-TNF alpha therapy efficacy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

69Actual

Label	Type	Description	Intervention Names
Adalimumab	Experimental	Adalimumab will be provided to trial participants as 0.8 ml single dose pre-filled syringes containing 40mg adalimumab each. A kit will be dispensed to he subject every two weeks, each kit containing one syringe.	Drug: Adalimumab

Name	Type	Description	Arm Group Labels	Other Names
Adalimumab	Drug		Adalimumab

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical response biomarkers (Assessment of Spondyloarthritis International Society (ASAS) 20 and Ankylosing Spondylitis Disease Activity Score (ASDAS)	To identify anti-TNF alpha clinical response biomarkers by microarrays and proteomics technology.	14 weeks

Secondary Outcomes

Measure	Description	Time Frame
QoL evaluation	To evaluate quality of life using ASQOL and SF-36 questionnaires	14 weeks
MRI progression	Rachis evaluation according to acute and structural lesions

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AS according to Portuguese Society of Rheumatology (SPR) guidelines (1984 modified New York Criteria, but allowing the use of MRI as imagiological criteria)
Patient enrolment followed national guidelines for TNF antagonist use for the treatment of AS
Adults between 18 to 75 years
Ability to provide informed consent
Corticosteroid therapy allowed (equivalent to ≤ 10 mg prednisone) and / or NSAID(nonsteroidal antiinflammatory drug), stable dose in 4 weeks before study initiation
Adequate contraception (barrier or hormonal) in men and women of childbearing age (patients and their partners
Adequate renal and hepatic function (2 times ULN)

Exclusion Criteria:

Current pregnancy or breastfeeding
Previous treatment with biologic DMARD's (disease-modifying antirheumatic drug)
Intraarticular injections or infiltrations of extraaxial joints and tendons within 28 days before or at screening, or intraarticular injections of sacroiliac joints ≤ 28 days before screening
History of rheumatic disorder other than AS
Other forms of spondylarthritis than AS
Any uncontrolled medical condition (e.g., uncontrolled diabetes mellitus, unstable ischemic heart disease)
History or signs of demyelinating disease
Malignancy (except for completely treated squamous or basal cell carcinoma)
Moderate to severe heart failure (NYHA class III/IV) Positive serology for hepatitis B, hepatitis C, or human immunodeficiency virus
Active or latent tuberculosis (TB) or histoplasmosis or other severe infections such as sepsis, and opportunistic infections
Infections requiring hospitalization or intravenous treatment with antibiotics within 30 days or oral treatment with antibiotics within 14 days before enrollment
Ankylosis of the spine (syndesmophytes presence at all levels from D12 to S1 in X-ray (XR) lateral view)
Hypersensitivity to the active substance or to any of the excipients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Fernando M. Pimentel-Santos, MD, PhD	NOVA Medical School/Faculdade de Ciências Médicas	Study Chair
Jaime C. Branco, MD, PhD	NOVA Medical School/Faculdade de Ciências Médicas	Principal Investigator

ID	Term
D013167	Spondylitis, Ankylosing
D025241	Spondylarthritis

ID	Term
D000089183	Axial Spondyloarthritis
D025242	Spondylarthropathies
D013166	Spondylitis
D013122	Spinal Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins