NCT02492217

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 8, 2015

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 28, 2018

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

3 years

First QC Date

July 3, 2015

Last Update Submit

October 30, 2020

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing SpondylitisadalimumabTNF-alpha agentsspondyloarthritisbiologic therapiesASbiomarkersefficacy prediction

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • QoL evaluation

    14 weeks

  • MRI progression

    14 weeks

Study Arms (1)

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

Interventions

AdalimumabDRUG
Adalimumab

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculdade de Ciências Médicas da Universidade Nova de Lisboa

Lisbon, Portugal

Location

MeSH Terms

Conditions

Spondylitis, AnkylosingSpondylarthritis

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2015

First Posted

July 8, 2015

Study Start

May 1, 2015

Primary Completion

May 1, 2018

Study Completion

May 28, 2018

Last Updated

November 3, 2020

Record last verified: 2020-10

Locations

PT(1)