Trial Outcomes & Findings for Methotrexate Polyglutamate Levels as a Marker for the Clinical Outcome in the Treatment of Rheumatoid Arthritis (NCT NCT00695188)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

19 participants

Primary outcome timeframe

16 weeks

Results posted on

2011-02-17

Participant Flow

Patients were included at the outpatient unit of the Kaiser-Franz-Josef-Hospital, Department for Rheumatology, if they fulfilled the inclusion criteria

Participant milestones

Participant milestones
Measure	Standard Dose Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)	High Dose Start with 25 mg MTX per week, administered orally
Overall Study STARTED	10	9
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Methotrexate Polyglutamate Levels as a Marker for the Clinical Outcome in the Treatment of Rheumatoid Arthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Dose n=10 Participants Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)	High Dose n=9 Participants Start with 25 mg MTX per week, administered orally	Total n=19 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Age Continuous	51 years STANDARD_DEVIATION 15 • n=5 Participants	62 years STANDARD_DEVIATION 7 • n=7 Participants	56 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment Austria	10 participants n=5 Participants	9 participants n=7 Participants	19 participants n=5 Participants

PRIMARY outcome

Timeframe: 16 weeks

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

Outcome measures

Outcome measures
Measure	Standard Dose n=10 Participants Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)	High Dose n=9 Participants Start with 25 mg MTX per week, administered orally
DAS-28 (Disease Activity Score in 28 Joints)	2.87 Units on a Scale Standard Deviation 0.93	2.66 Units on a Scale Standard Deviation 0.11

SECONDARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome data not reported

Adverse Events

Standard Dose

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

High Dose

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Standard Dose n=10 participants at risk Escalating dose (Start with 15 mg MTX/week, escalating dose until 25 mg/week, administered orally)	High Dose n=9 participants at risk Start with 25 mg MTX per week, administered orally
Gastrointestinal disorders Nausea	50.0% 5/10 • Number of events 5	44.4% 4/9 • Number of events 4

Additional Information

Eva-Luise Hobl

Department of Clinical Pharmacology, Medical University of Vienna

Phone: +43 1 40400 2981

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60