NCT01033656

Brief Summary

An open, randomized, parallel-group, comparative, multicentre study. Patients on corticosteroids (plus conventional therapy) will be randomized to receive anakinra (Kineret®), or one of the following: methotrexate, azathioprine, leflunomide, cyclosporin A or sulphasalazine. Patients enter the study if considered refractory to corticosteroids (prednisolone equivalent ≥10 mg/day) at the time of randomization. The randomized phase of the study will be followed by an open-label extension (OLE) phase, to follow-up drug survival, efficacy, tolerability and disease-related parameters of long-term treatment with anakinra or one of the study DMARDs or a combination of study drugs for additional 28 weeks.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
23

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2005

Typical duration for phase_2

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

December 1, 2005

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

December 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

March 6, 2017

Status Verified

March 1, 2017

Enrollment Period

4.2 years

First QC Date

December 15, 2009

Last Update Submit

March 3, 2017

Conditions

Adult-Onset Still's Disease

Keywords

adult-onset Still's diseaseanakinraprednisolonedisease-modifying antirheumatic drugmethotrexateefficacypatients

Outcome Measures

Primary Outcomes (1)

  • Number of patients reaching remission of the disease, after eight weeks of the randomized study treatment (Remission: afebrile and normalization of acute phase reactants)

    8 weeks

Study Arms (2)

Anakinra

EXPERIMENTAL

experimental drug of study

Drug: anakinra

comparator

ACTIVE COMPARATOR

comparators:methotrexate, azathioprine, leflunomide or supfasalazine

Drug: comparators

Interventions

anakinraDRUG

100 mg subcutaneous injection daily

Also known as: Interleukin-1 receptor antagonist
Anakinra
comparatorsDRUG

po drugs, comparators

Also known as: methotrexate, azathioprine, leflunomide, sufalalazine
comparator

Eligibility Criteria

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

You may qualify if:

  • Must be diagnosed with AOSD according to preliminary classification by Yamaguchi (1992).
  • Other diseases with similar symptoms must be excluded. Has been exposed to a corticosteroid for ≥2 months prior to randomization for AOSD.
  • Needs a prednisolone dose ≥10 mg/day or equivalent, yet unacceptable disease activity determined by the investigator.
  • Anti-TNF agents must be discontinued 4 to 8 weeks prior to commencing study medication.

You may not qualify if:

  • Use of corticosteroids (prednisolone equivalent \<10 mg/day.
  • History of recurrent or chronic infection, including:
  • tuberculosis
  • any malignancy
  • any other major chronic inflammatory disease syndrome
  • drug or alcohol abuse
  • known positivity for hepatitis B, C or HIV.
  • Use of anti-TNF agents during ≤4 weeks (etanercept) or≤8 weeks (infliximab or adalimumab) prior to randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ann Kataja Knight

Uppsala, 75185, Sweden

Location

Related Publications (1)

  • Nordstrom D, Knight A, Luukkainen R, van Vollenhoven R, Rantalaiho V, Kajalainen A, Brun JG, Proven A, Ljung L, Kautiainen H, Pettersson T. Beneficial effect of interleukin 1 inhibition with anakinra in adult-onset Still's disease. An open, randomized, multicenter study. J Rheumatol. 2012 Oct;39(10):2008-11. doi: 10.3899/jrheum.111549. Epub 2012 Aug 1.

    PMID: 22859346DERIVED

MeSH Terms

Conditions

Still's Disease, Adult-Onset

Interventions

Interleukin 1 Receptor Antagonist ProteinReceptors, Interleukin-6MethotrexateAzathioprineLeflunomide

Condition Hierarchy (Ancestors)

Arthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsReceptors, InterleukinReceptors, CytokineReceptors, ImmunologicReceptors, Cell SurfaceMembrane ProteinsAminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesNucleosidesNucleic Acids, Nucleotides, and NucleosidesIsoxazolesAzolesHeterocyclic Compounds, 1-Ring

Study Officials

  • Dan C Nordstrom, MD, PhD

    Helsinki University Hospital, Department of Medicine

    PRINCIPAL INVESTIGATOR

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
ass.prof

Study Record Dates

First Submitted

December 15, 2009

First Posted

December 16, 2009

Study Start

December 1, 2005

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

March 6, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)