Rheumatoid ArthritisPhase 4DMIRANCT01404429

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

A Phase 4 study testing Methotrexate in people with Rheumatoid Arthritis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Rheumatoid Arthritis
What is being tested?: Methotrexate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteIndia
Study dates: May 2011to Jul 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Pregnant/Breastfeeding
Ongoing/Recent treatment with methotrexate (2 months)
Chronic liver disease
Renal failure
Any leucopenia or thrombocytopenia
Breast-feeding

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

India1 site

New OPD Block, Rheumatology Clinic, Level 3
Chandigarh, Chandigarh, 160012

Other trials in India

About this study

Official title: Randomized Controlled Trial of Two Different Starting Doses of Methotrexate in Rheumatoid Arthritis

Hypothesis: There will be no difference in the adverse effects, but better and faster control of disease when starting with a higher methotrexate dose

Conditions: Rheumatoid Arthritis
Being tested: Methotrexate
Keywords: Rheumatoid arthritis, Active
Medical subject headings: Arthritis, Rheumatoid, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MethotrexateDrug
Also called MEXATE
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

Study groups in NCT01404429
Study group	Role	What they receive
Methotrexate 7.5 mg per week	Active comparator	Not described Receives: Drug: Methotrexate
Methotrexate 15 mg per week	Experimental	Not described Receives: Drug: Methotrexate

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 12 weeks
Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)
Measured: 3 months

Secondary outcomes (3)

Proportion of Patients Who Withdrew Because of Any Cause
Measured: 3 months
Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU)
Measured: 3 months
Proportion Who Withdrew Due to Intolerance
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2011Jul 2012

First posted28 Jul 2011 (estimated)
Study startMay 2011
Primary completionJun 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01404429
Sponsor's protocol ID: NKG/992
Acronym: DMIRA
Status last verified: Sep 2014
First submitted: 26 Jul 2011
Last updated: 16 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 24976447

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Rheumatoid Arthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Controlled Trial of Two Different Starting Doses of Methotrexate in Rheumatoid Arthritis
ClinicalTrials.gov ID: NCT01404429
Acronym / sponsor ID: DMIRA / NKG/992
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis, Active
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
Study start: May 2011
Primary completion: Jun 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 28 Jul 2011 (estimated)
Results: Posted 5 Sep 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Hypothesis: There will be no difference in the adverse effects, but better and faster control of disease when starting with a higher methotrexate dose

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Methotrexate 7.5 mg per week	Active comparator	Drug: Methotrexate
Methotrexate 15 mg per week	Experimental	Drug: Methotrexate

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (11 listed)

Pregnant/Breastfeeding
Ongoing/Recent treatment with methotrexate (2 months)
Chronic liver disease
Renal failure
Any leucopenia or thrombocytopenia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MethotrexateAlso: MEXATEDifferent 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	Drug	Methotrexate 15 mg per week, Methotrexate 7.5 mg per week

Primary outcome

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
Time frame: 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
Patients With Good Response (Final DAS28-3 Less Than 3.2 and Fall More Than 1.2)
Time frame: 3 months

3 secondary outcomes

Proportion of Patients Who Withdrew Because of Any Cause
Time frame: 3 months
Proportion Requiring Stoppage/Decrease/Inability to Hike MTX Due to Cytopenia or Transaminitis (SGOT or SGPT More Than 80IU)
Time frame: 3 months
Proportion Who Withdrew Due to Intolerance
Time frame: 3 months

Results and safety

Results posted to the registry on 5 Sep 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Methotrexate 7.5 mg Per Week	47	38
Methotrexate 15 mg Per Week	53	46

Primary outcome: 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

Time frame: 12 weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Methotrexate 7.5 mg Per Week n = 47	Methotrexate 15 mg Per Week n = 53
Value	-0.47 (0.86)	-0.55 (0.79)

Methotrexate 7.5 mg Per Week vs Methotrexate 15 mg Per Week: Mean Difference (Final Values): 0.14 (95% CI -0.26 to 0.54), p = 0.6, t-test, 2 sided

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

Time frame: 3 months. Number. Unit: participants

Measure	Methotrexate 7.5 mg Per Week n = 47	Methotrexate 15 mg Per Week n = 53
Value	0	1

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Methotrexate 7.5 mg Per Week	0 of 47 (0%)	9 of 47 (19.1%)	Not reported
Methotrexate 15 mg Per Week	0 of 53 (0%)	22 of 53 (41.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24976447Dhir 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.
published manuscriptLink provided by the sponsor.

Related trials for Rheumatoid Arthritis

RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
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Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
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RecruitingPhase 1
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Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Methotrexate in people with Rheumatoid Arthritis, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01404429, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2014.