NCT00695188

Brief Summary

The primary objective is to determine whether erythrocyte polyglutamate levels are associated with objective clinical response in patients with rheumatoid arthritis after oral administration of low-dose methotrexate.The secondary aim of this study is to compare the efficacy and safety of standard dose methotrexate versus a higher starting dose.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started May 2008

Geographic Reach
1 country

2 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

May 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 9, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
3 months until next milestone

Results Posted

Study results publicly available

February 15, 2011

Completed
Last Updated

February 17, 2011

Status Verified

August 1, 2009

Enrollment Period

2.6 years

First QC Date

June 9, 2008

Results QC Date

December 20, 2010

Last Update Submit

February 15, 2011

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritisMTX polyglutamatesclinical outcome

Outcome Measures

Primary Outcomes (1)

  • DAS-28 (Disease Activity Score in 28 Joints)

    DAS stands for "Disease Activity Score" and is a measure of the activity of rheumatoid arthritis. In Europe the DAS is the recognized standard in research and clinical practice. The following parameters are included in the calculation: * Number of joints tender to the touch (TEN) * Number of swollen joints (SW) * Erythrocyte sedimentation rate (ESR) * Patient assessment of disease activity (VAS; mm) The DAS-28 is evaluated using a scale: 0 - 3.2: low disease activity 3.2 - 5.1: moderate disease activity \> 5.1: severe disease activity

    16 weeks

Secondary Outcomes (1)

  • HAQ (Health Assessment Questionnaire)

    16 weeks

Study Arms (2)

Standard dose

OTHER

Escalating dose

Drug: methotrexate

High dose

ACTIVE COMPARATOR

25 mg

Drug: methotrexate

Interventions

methotrexateDRUG

oral administration Escalating dose (15, 20, 25 mg)

Standard dose

Eligibility Criteria

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

You may qualify if:

  • MTX-naive
  • Age \> 18 years
  • DAS-28 \> 3.2
  • American College of Rheumatology-criteria for RA
  • Chest-X-ray
  • Informed consent
  • Prednisolon \< 10 mg a day

You may not qualify if:

  • Pregnancy
  • Lactation
  • Renal and hepatic impairment
  • Malignant diseases (last 5 years)
  • Contraindications
  • Human Immunodeficiency Virus (HIV), Hepatitis B and C

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Kaiser-Franz-Josef-Spital

Vienna, 1100, Austria

Location

Rheumazentrum Wien Oberlaa

Vienna, 1100, Austria

Location

Related Publications (1)

  • Hobl EL, Mader RM, Jilma B, Duhm B, Mustak M, Broll H, Hogger P, Erlacher L. A randomized, double-blind, parallel, single-site pilot trial to compare two different starting doses of methotrexate in methotrexate-naive adult patients with rheumatoid arthritis. Clin Ther. 2012 May;34(5):1195-203. doi: 10.1016/j.clinthera.2012.03.059. Epub 2012 Apr 18.

    PMID: 22516039DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Eva-Luise Hobl
Organization
Department of Clinical Pharmacology, Medical University of Vienna
eva-luise.hobl@meduniwien.ac.at
+43 1 40400 2981

Study Officials

  • Hans Broell, Prof. Dr.

    Ludwig-Boltzmann-Institut fuer Rheumatologie und Balneologie

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2008

First Posted

June 11, 2008

Study Start

May 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

February 17, 2011

Results First Posted

February 15, 2011

Record last verified: 2009-08

Locations

AU(2)