NCT00189878

Brief Summary

The purpose of this study is to determine whether methotrexate produces significant improvement in chronic idiopathic urticaria, compared with placebo

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2003

Longer than P75 for phase_2

Status
terminated

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

August 1, 2003

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

5 years

First QC Date

September 11, 2005

Last Update Submit

February 18, 2016

Conditions

Urticaria

Keywords

chronic idiopathic urticariamethotrexate

Outcome Measures

Primary Outcomes (1)

  • A positive response to treatment (a reduction to <25% of baseline urticaria activity scores)

    8 weeks

Study Arms (2)

1 methotrexate

ACTIVE COMPARATOR

patient to receive methotrexate

Drug: Methotrexate (drug)

2 Placebo

PLACEBO COMPARATOR

given placebo capsules

Drug: placebo capsules

Interventions

Methotrexate (drug)DRUG

Methotrexate 10 to 15 mg weekly for 8 weeks

1 methotrexate
placebo capsulesDRUG

4-6 placebo capsules - identical to capsules containing methotrexate

2 Placebo

Eligibility Criteria

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

You may qualify if:

  • severe unremitting chronic idiopathic urticaria
  • disease resistant to treatment with antihistamines
  • aged 18 years or more

You may not qualify if:

  • predominant physical urticaria
  • urticarial vasculitis
  • any contraindication to the use of methotrexate, eg. pregnancy / breast feeding, women wanting to conceive or man wanting to father a child within 12 months of entry, use of drugs which interact, underlying medical conditions
  • use of immunosuppressant within 4 weeks of entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

UrticariaChronic Urticaria

Interventions

MethotrexatePharmaceutical Preparations

Condition Hierarchy (Ancestors)

Skin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ruth A Sabroe, FRCP, MD

    Barnsley Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 19, 2005

Study Start

August 1, 2003

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

February 19, 2016

Record last verified: 2016-02