Trial Outcomes & Findings for Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis (NCT NCT01404429)

NCT ID: NCT01404429

Last Updated: 2014-09-16

Results Overview

DAS28-3 is disease activity score using 28 joints and using 3 variables (tender and swollen joint count for 28 joints and ESR(westergren 1st hour) It ranges from 0 to 9.3 where a lower value implies lower disease activity

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 100 participants
• Primary outcome timeframe: 12 weeks
• Results posted on: 2014-09-16

Participant Flow

Participant milestones

Measure	Methotrexate 7.5 mg Per Week Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)	Methotrexate 15 mg Per Week Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
Overall Study STARTED	47	53
Overall Study COMPLETED	38	46
Overall Study NOT COMPLETED	9	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis

Baseline characteristics by cohort

Measure	Methotrexate 7.5 mg Per Week n=47 Participants Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)	Methotrexate 15 mg Per Week n=53 Participants Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)	Total n=100 Participants Total of all reporting groups
Age, Continuous	44.5 years STANDARD_DEVIATION 10.3 • n=5 Participants	42.8 years STANDARD_DEVIATION 11.2 • n=7 Participants	43.6 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	41 Participants n=7 Participants	78 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 weeks

DAS28-3 is disease activity score using 28 joints and using 3 variables (tender and swollen joint count for 28 joints and ESR(westergren 1st hour) It ranges from 0 to 9.3 where a lower value implies lower disease activity

Outcome measures

Measure	Methotrexate 7.5 mg Per Week n=47 Participants Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)	Methotrexate 15 mg Per Week n=53 Participants Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
Mean Change in the DAS28-3 (Disease Activity Score Using 28 Joints and Using 3 Variables) - Difference Between This Score at 12 Weeks and This Score at Baseline	-0.47 units on a scale Standard Deviation 0.86	-0.55 units on a scale Standard Deviation 0.79

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Measure	Methotrexate 7.5 mg Per Week n=47 Participants Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)	Methotrexate 15 mg Per Week n=53 Participants Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)	0 participants	1 participants

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Measure	Methotrexate 7.5 mg Per Week n=47 Participants Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)	Methotrexate 15 mg Per Week n=53 Participants Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
Proportion of Patients Who Withdrew Because of Any Cause	9 participants	7 participants

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Measure	Methotrexate 7.5 mg Per Week n=47 Participants Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)	Methotrexate 15 mg Per Week n=53 Participants Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
Proportion Who Withdrew Due to Intolerance	2 participants	2 participants

Adverse Events

Methotrexate 7.5 mg Per Week

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Methotrexate 15 mg Per Week

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Methotrexate 7.5 mg Per Week n=47 participants at risk Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)	Methotrexate 15 mg Per Week n=53 participants at risk Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
Gastrointestinal disorders Nausea and vomiting	19.1% 9/47 • 12 weeks	41.5% 22/53 • 12 weeks

Additional Information

Varun Dhir, Assistant Professor, Internal Medicine

PGIMER, India

Phone: +91-8872229998

Email: varundhir@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place