Study of Two Different Starting Doses of Methotrexate When Starting Treatment in Rheumatoid Arthritis
NCT ID: NCT01404429
Last Updated: 2014-09-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
100 participants
INTERVENTIONAL
2011-05-31
2012-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Hypothesis: There will be no difference in the adverse effects, but better and faster control of disease when starting with a higher methotrexate dose
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Study of Different Doses of Folic Acid in Combination With Methotrexate in Rheumatoid Arthritis
NCT01583959
A Study to Assess CH1504 in Patients With Active Rheumatoid Arthritis
NCT00658047
A Study to Investigate How JNJ-39758979 May Affect the Plasma Levels of Methotrexate in Rheumatoid Arthritis Participants
NCT01442545
Comparison of Combination Disease Modifying Antirheumatic Drugs With Methotrexate Therapy in Early Rheumatoid Arthritis
NCT02644499
Dose Ranging Study of ART621 in Subjects Diagnosed With Rheumatoid Arthritis Taking Methotrexate
NCT00928317
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Methotrexate 7.5 mg per week
Methotrexate
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
Methotrexate 15 mg per week
Methotrexate
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Methotrexate
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
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Post Graduate Institute of Medical Education and Research, Chandigarh
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Varun Dhir
Assistant Professor, Internal Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
New OPD Block, Rheumatology Clinic, Level 3
Chandigarh, Chandigarh, India
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Related Links
Access external resources that provide additional context or updates about the study.
published manuscript
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NKG/992
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.