NCT01404429

Brief Summary

To use different starting doses of methotrexate (7.5 mg per week) versus 15 mg per week in patients with rheumatoid arthritis, followed by similar hiking up of dose (2.5 mg per 2 weeks, till max of 25 mg per week). To look at the effect on efficacy ( or speed of efficacy) versus the adverse effects. Hypothesis: There will be no difference in the adverse effects, but better and faster control of disease when starting with a higher methotrexate dose

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_4 rheumatoid-arthritis

Timeline
Completed

Started May 2011

Shorter than P25 for phase_4 rheumatoid-arthritis

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

May 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 28, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

September 5, 2014

Completed
Last Updated

September 16, 2014

Status Verified

September 1, 2014

Enrollment Period

1.1 years

First QC Date

July 26, 2011

Results QC Date

August 9, 2014

Last Update Submit

September 5, 2014

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid arthritisActive

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    12 weeks

  • Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)

    3 months

Secondary Outcomes (3)

  • Proportion of Patients Who Withdrew Because of Any Cause

    3 months

  • Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU)

    3 months

  • Proportion Who Withdrew Due to Intolerance

    3 months

Study Arms (2)

Methotrexate 7.5 mg per week

ACTIVE COMPARATOR
Drug: Methotrexate

Methotrexate 15 mg per week

EXPERIMENTAL
Drug: Methotrexate

Interventions

MethotrexateDRUG

Different doses for both arms followed by similar escalation (2.5 mg every 15 d) till max of 25 mg per week or 3 months completed

Also known as: MEXATE
Methotrexate 15 mg per weekMethotrexate 7.5 mg per week

Eligibility Criteria

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

You may qualify if:

  • Patients with rheumatoid arthritis fulfilling the ACR 1987 criteria
  • Between 18 years to 65 year of age
  • Having active disease Disease activity score (28 joints) DAS28-3 more than 5.1
  • Not on methotrexate in the last 2 months
  • Permitted to be on corticosteroids if the dosages stable for at least 1 weeks before randomization and if corticosteroid dosage less than 10 mg/day
  • Permitted to be on other disease modifying anti-rheumatic drug (DMARD) like sulfasalazine, leflunomide and hydroxychloroquine, if dosages stable for at least 2 weeks before randomization

You may not qualify if:

  • Pregnant/Breastfeeding
  • Ongoing/Recent treatment with methotrexate (2 months)
  • Chronic liver disease
  • Renal failure
  • Any leucopenia or thrombocytopenia
  • Breast-feeding
  • Desirous of pregnancy in the next 6 months
  • Known Hepatitis B or C positive
  • Known clinically relevant chronic lung disease: ILD
  • Tuberculosis or other active infections
  • Known HIV positive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New OPD Block, Rheumatology Clinic, Level 3

Chandigarh, Chandigarh, 160012, India

Location

Related Publications (1)

  • Dhir V, Singla M, Gupta N, Goyal P, Sagar V, Sharma A, Khanna S, Singh S. Randomized controlled trial comparing 2 different starting doses of methotrexate in rheumatoid arthritis. Clin Ther. 2014 Jul 1;36(7):1005-15. doi: 10.1016/j.clinthera.2014.05.063. Epub 2014 Jun 26.

    PMID: 24976447DERIVED

Related Links

MeSH Terms

Conditions

Arthritis, RheumatoidMotor Activity

Interventions

Methotrexate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

Title
Varun Dhir, Assistant Professor, Internal Medicine
Organization
PGIMER, India
varundhir@gmail.com
+91-8872229998

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Internal Medicine

Study Record Dates

First Submitted

July 26, 2011

First Posted

July 28, 2011

Study Start

May 1, 2011

Primary Completion

June 1, 2012

Study Completion

July 1, 2012

Last Updated

September 16, 2014

Results First Posted

September 5, 2014

Record last verified: 2014-09

Locations

IN(1)