NCT01895764

Brief Summary

The purpose of this study is to determine if association of methotrexate with adalimumab leads to decrease immunogenicity beside adalimumab alone in Ankylosing Spondylitis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2013

Typical duration for phase_4

Geographic Reach
1 country

11 active sites

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

March 20, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 24, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 27, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 27, 2015

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

2.1 years

First QC Date

April 24, 2013

Last Update Submit

December 15, 2025

Conditions

Ankylosing Spondylitis

Keywords

ankylosing spondylitis

Outcome Measures

Primary Outcomes (1)

  • presence or absence of antibodies against adalimumab

    6 months

Secondary Outcomes (3)

  • Change from baseline of the Ankylosing Spondylitis Disease Activity Score (ASDAS)

    6 months

  • Change from baseline of T and B cells concentrations.

    6 months

  • Change from baseline of "APRIL" and "TNF alpha" concentrations

    6 months

Study Arms (2)

Adalimumab

ACTIVE COMPARATOR

adalimumab 40mg every 2 weeks

Drug: Adalimumab

Adalimumab + Methotrexate

EXPERIMENTAL

adalimumab 40mg every 2 weeks and methotrexate 10mg per week

Drug: AdalimumabDrug: Methotrexate

Interventions

MethotrexateDRUG

methotrexate, subcutaneous injection, 10mg per week, week -2 until week 26

Also known as: Metoject
Adalimumab + Methotrexate
AdalimumabDRUG

adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26

Also known as: Humira
AdalimumabAdalimumab + Methotrexate

Eligibility Criteria

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

You may qualify if:

  • Subject 18 years of age or older
  • Able and willing to give written informed consent and to comply with the requirements of the study protocol
  • Subject met the definition of Ankylosing Spondylitis (AS) based on ASAS Criteria
  • Subject with active AS, has had an inadequate response, an intolerance or an to one or more nonsteroidal anti-inflammatory drugs

You may not qualify if:

  • Previous adalimumab treatment or previous treatment with more than one anti TNF alpha therapy.
  • Surgery scheduled during study
  • Female subject without method of contraception
  • Contraindication to adalimumab or methotrexate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Rhumatologie, CH de BLOIS

Blois, 41000, France

Location

Rhumatologie, CHRU de BREST

Brest, 29609, France

Location

Rhumatologie, CHD LA ROCHE SUR YON

La Roche-sur-Yon, 85925, France

Location

Rhumatologie, CHR du MANS

Le Mans, 72037, France

Location

Rhumatologie, CHRU de NANTES

Nantes, 44093, France

Location

Rhumatologie / IPROS, CHR d'ORLEANS

Orléans, 45032, France

Location

Rhumatologie, CHRU de POITIERS

Poitiers, 86021, France

Location

Rhumatologie, CHRU de RENNES

Rennes, 35203, France

Location

Rhumatologie, CH de SAINT BRIEUC

Saint-Brieuc, 22027, France

Location

Médecine polyvalente, CH de SAINT NAZAIRE

Saint-Nazaire, 44606, France

Location

Rhumatologie, CHRU de TOURS

Tours, 37044, France

Location

Related Publications (1)

  • Ducourau E, Rispens T, Samain M, Dernis E, Le Guilchard F, Andras L, Perdriger A, Lespessailles E, Martin A, Cormier G, Armingeat T, Devauchelle-Pensec V, Gervais E, Le Goff B, de Vries A, Piver E, Paintaud G, Desvignes C, Ternant D, Watier H, Goupille P, Mulleman D. Methotrexate effect on immunogenicity and long-term maintenance of adalimumab in axial spondyloarthritis: a multicentric randomised trial. RMD Open. 2020 Jan;6(1):e001047. doi: 10.1136/rmdopen-2019-001047. Epub 2020 Jan 9.

    PMID: 31958280RESULT

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

AdalimumabMethotrexate

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Emilie DUCOURAU, MD

    CHRU de TOURS

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2013

First Posted

July 10, 2013

Study Start

March 20, 2013

Primary Completion

April 27, 2015

Study Completion

April 27, 2015

Last Updated

December 22, 2025

Record last verified: 2025-12

Locations

FR(11)