NCT07094880

Brief Summary

Methotrexate use is important for the treatment of Rheumatoid arthritis. Some patients can not tolerate oral methotrexate. So subcutaneous may help to overcome it.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2015

Shorter than P25 for phase_4

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

June 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
9 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 30, 2025

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

1 year

First QC Date

May 29, 2025

Last Update Submit

July 23, 2025

Conditions

Methotrexate Adverse ReactionAdvantage of Using Subcutaneous Route for Methotrexate

Keywords

Oral MethotrexateSubcutaneous MethotrexateRheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • American College of Rheumatology 20

    20% reduction in disease activity

    "From enrollment to the end of treatment at 16 weeks"

Study Arms (2)

Group A

ACTIVE COMPARATOR

Oral Methotrexate 25 mg will be given weekly

Drug: Tab. Methotrexate 25mg/week

Group B

ACTIVE COMPARATOR

Subcutaneous methotrexate will be given 25mg/week

Drug: Inj. Methotrexate 25mg/week

Interventions

Tab. Methotrexate 25mg/weekDRUG

Tab. Methotrexate will be given orally in one arm at a dose of 25 mg/week

Group A
Inj. Methotrexate 25mg/weekDRUG

Inj. Methotrexate 25 mg/week will be given subcutaneously in another arm

Group B

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient must fulfill the ACR 1987 revised criteria
  • The disease should be active
  • Age 18-70 years

You may not qualify if:

  • Presence of other rheumatologic disorder
  • Pregnancy, lactating mother and women with child bearing potential failing to confirm adequate contraception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Professor, Bangladesh Medical University

Study Record Dates

First Submitted

May 29, 2025

First Posted

July 30, 2025

Study Start

June 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 30, 2025

Record last verified: 2025-07