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

Primary Purpose

Ankylosing Spondylitis

Status

Completed

Phase

Phase 4

Locations

Portugal

Study Type

Interventional

Intervention

Adalimumab

About this trial

This is an interventional treatment trial for Ankylosing Spondylitis focused on measuring Ankylosing Spondylitis, adalimumab, TNF-alpha agents, spondyloarthritis, biologic therapies, AS, biomarkers, efficacy prediction

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Faculdade de Ciências Médicas da Universidade Nova de Lisboa

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Adalimumab

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

QoL evaluation

To evaluate quality of life using ASQOL and SF-36 questionnaires

MRI progression

Rachis evaluation according to acute and structural lesions

Full Information

NCT ID

NCT02492217

First Posted

July 3, 2015

Last Updated

October 30, 2020

Sponsor

Universidade Nova de Lisboa

1. Study Identification

Unique Protocol Identification Number

NCT02492217

Brief Title

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

Official Title

Biomarkers Identification of Anti-TNF α Agent's Efficacy in Ankylosing Spondylitis Patients Using a Transcriptome Analysis and Mass Spectrometry

Study Type

Interventional

2. Study Status

Record Verification Date

October 2020

Overall Recruitment Status

Completed

Study Start Date

May 2015 (Actual)

Primary Completion Date

May 2018 (Actual)

Study Completion Date

May 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universidade Nova de Lisboa

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis, adalimumab, TNF-alpha agents, spondyloarthritis, biologic therapies, AS, biomarkers, efficacy prediction

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

69 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Adalimumab

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Adalimumab

Primary Outcome Measure Information:

Title

Clinical response biomarkers (Assessment of Spondyloarthritis International Society (ASAS) 20 and Ankylosing Spondylitis Disease Activity Score (ASDAS)

Description

To identify anti-TNF alpha clinical response biomarkers by microarrays and proteomics technology.

Time Frame

14 weeks

Secondary Outcome Measure Information:

Title

QoL evaluation

Description

To evaluate quality of life using ASQOL and SF-36 questionnaires

Time Frame

14 weeks

Title

MRI progression

Description

Rachis evaluation according to acute and structural lesions

Time Frame

14 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fernando M. Pimentel-Santos, MD, PhD

Organizational Affiliation

NOVA Medical School/Faculdade de Ciências Médicas

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jaime C. Branco, MD, PhD

Organizational Affiliation

NOVA Medical School/Faculdade de Ciências Médicas

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculdade de Ciências Médicas da Universidade Nova de Lisboa

City

Lisbon

Country

Portugal

12. IPD Sharing Statement

Learn more about this trial

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

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