NCT02456363

Brief Summary

Assessed using (1) Adalimumab(Humira) and NSAIDs (2) Use only Adalimumab(Humira) treatment of ankylosing spondylitis patient safety and efficacy.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2009

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2014

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

May 28, 2015

Status Verified

May 1, 2015

Enrollment Period

9.9 years

First QC Date

December 14, 2014

Last Update Submit

May 26, 2015

Conditions

Ankylosing Spondylitis

Keywords

AdalimumabNSAIDssafetyefficacy

Outcome Measures

Primary Outcomes (1)

  • mSASSS (Modified Stoke Ankylosing Spondylitis Spinal Score)

    weeks 92 of the spinal injury

    weeks 92

Study Arms (4)

NSAIDs(+) and sulfasalazine(+)

EXPERIMENTAL

use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine

Biological: TNF alphaDrug: NSAIDs and sulfasalazine

NSAIDs(+) and sulfasalazine(-)

EXPERIMENTAL

use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of NSAIDs and no sulfasalazine

Biological: TNF alphaDrug: NSAIDs and sulfasalazine

NSAIDs(-) and sulfasalazine(+)

EXPERIMENTAL

use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) combine with use of sulfasalazine and no NSAIDs

Biological: TNF alphaDrug: NSAIDs and sulfasalazine

NSAIDs(-) and sulfasalazine(-)

EXPERIMENTAL

use TNF alpha: Adalimumab (Humira)、Etanercept (Enbrel) or Golimumab (Simponi) neither NSAIDs nor sulfasalazine

Biological: TNF alpha

Interventions

TNF alphaBIOLOGICAL

Depending on patient need to use different TNF alpha

Also known as: Drug: Adalimumab (Humira), Drug: Etanercept (Enbrel), Drug: Golimumab (Simponi)
NSAIDs(+) and sulfasalazine(+)NSAIDs(+) and sulfasalazine(-)NSAIDs(-) and sulfasalazine(+)NSAIDs(-) and sulfasalazine(-)
NSAIDs and sulfasalazineDRUG

randomized case, combine with use of NSAIDs(-/+) and sulfasalazine(-/+)

Also known as: Drug: Arcoxia, Drug: Celebrex, Drug: Tonec, Drug: Mobic, Drug: sulfasalazine
NSAIDs(+) and sulfasalazine(+)NSAIDs(+) and sulfasalazine(-)NSAIDs(-) and sulfasalazine(+)

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years old
  • HLA B27 positive
  • X ray examination
  • Clinical symptoms and physical examination, the following three conditions are subject to at least two:
  • i.lower back pain and morning stiffness symptoms persist more than 3 months ii. lumbar activity is restricted iii. chest expansion is restricted
  • Active disease for four weeks or more (continue two examination BASDAI\>6, ESR\> 28 mm/1 hr and CRP\>1 mg/dl)

You may not qualify if:

  • pregnant or breast-feeding women
  • patients with active infections
  • highly infectious patients
  • Cancer or precancerous condition of the patient
  • multiple sclerosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taiwan

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Tumor Necrosis FactorsAdalimumabEtanerceptgolimumabAnti-Inflammatory Agents, Non-SteroidalSulfasalazineEtoricoxibCelecoxibMeloxicam

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsSerum GlobulinsGlobulinsImmunoglobulin Fc FragmentsImmunoglobulin FragmentsPeptide FragmentsImmunoglobulin Constant RegionsReceptors, Tumor Necrosis FactorReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane ProteinsAnalgesics, Non-NarcoticAnalgesicsSensory System AgentsPeripheral Nervous System AgentsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnti-Inflammatory AgentsTherapeutic UsesAntirheumatic AgentsSulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzenesulfonamidesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPyrazolesAzolesThiazinesThiazoles

Study Officials

  • Wei C- C, M.D.

    Chung Shan Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Department of Critical Care Medicine and Division of Pulmonary Medicine

Study Record Dates

First Submitted

December 14, 2014

First Posted

May 28, 2015

Study Start

November 1, 2009

Primary Completion

October 1, 2019

Study Completion

December 1, 2019

Last Updated

May 28, 2015

Record last verified: 2015-05

Locations

TW(1)