Trial · NCT02930343
Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy
NCT02930343, Phase 3, Terminated, Jawaharlal Institute of Postgraduate Medical Education & Research; results first posted 2021-06-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy. Trials, record NCT02930343. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02930343
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy
- NCT number
- NCT02930343
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 136 participants, actual
- Lead sponsor
- Jawaharlal Institute of Postgraduate Medical Education & Research
- Conditions
- Rheumatoid Arthritis
- Interventions
- Methotrexate, Leflunomide, Hydroxychloroquine, Prednisolone, Folic Acid, Sulfasalazine
- First posted
- 2016-10-12
- Last updated
- 2021-07-27
- Results first posted
- 2021-06-10
- Limitations and caveats
- Early termination resulted in enrollment of 136 patients instead of 140 patients.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients Achieving Good EULAR Response at the End of 12 Weeks | 12 weeks | EULAR response criteria for Rheumatoid arthritis includes- estimation of DAS 28 ESR, that includes- 1. Tender joint count 28 2. Swollen joint count 28 3. ESR 4. Patient global assessment of health |
| Secondary | Disease Activity as Per Ultrasound-7 (US-7) Score | 12 weeks | Ultrasound 7 score (US-7) Calculates ultrasound score in 7 joints using greyscale and power doppler to evaluate for disease activity (synovitis, tenosynovitis) and damage (erosions) Score minimum value= 0 Maximum value = 108 Higher score indicates worse disease |
| Secondary | Number of Participants With Adverse Drug Reactions | 24 weeks | Infections, transaminitis, nausea, vomiting, derranged renal function tests etc |
| Secondary | Indian Health Assessment Questionnaire (iHAQ) | 12 weeks | Indian version of Health assessment Questionnaire (iHAQ) Comprises of 12 questions relating to functional activity iHAQ score ranges from 0 to 3 (minimum 0, maximum 3) Higher scores indicate more disability |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients Achieving Good EULAR Response at the End of 12 Weeks | 12 weeks | Analysis was done by intention to treat | participants | NUMBER |
| SECONDARY | Disease Activity as Per Ultrasound-7 (US-7) Score | 12 weeks | intention to treat analysis | units on a scale | MEDIAN |
| SECONDARY | Number of Participants With Adverse Drug Reactions | 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Indian Health Assessment Questionnaire (iHAQ) | 12 weeks | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients Achieving Good EULAR Response at the End of 12 Weeks | Group 1- MTX+LEF+HCQ | 40 | participants | ||
| Number of Patients Achieving Good EULAR Response at the End of 12 Weeks | Group 2- MTX+SSZ+HCQ | 37 | participants | ||
| Disease Activity as Per Ultrasound-7 (US-7) Score | Group 1- MTX+LEF+HCQ | 3.5 | Inter-Quartile Range 0 to 6 | units on a scale | |
| Disease Activity as Per Ultrasound-7 (US-7) Score | Group 2- MTX+SSZ+HCQ | 4 | Inter-Quartile Range 0 to 4.5 | units on a scale | |
| Number of Participants With Adverse Drug Reactions | Group 1- MTX+LEF+HCQ | Total number of any adverse events | 15 | Participants | |
| Number of Participants With Adverse Drug Reactions | Group 2- MTX+SSZ+HCQ | Total number of any adverse events | 21 | Participants | |
| Number of Participants With Adverse Drug Reactions | Group 1- MTX+LEF+HCQ | Serious adverse events | 0 | Participants | |
| Number of Participants With Adverse Drug Reactions | Group 2- MTX+SSZ+HCQ | Serious adverse events | 0 | Participants | |
| Number of Participants With Adverse Drug Reactions | Group 1- MTX+LEF+HCQ | Any gastrointestinal adverse reaction | 11 | Participants | |
| Number of Participants With Adverse Drug Reactions | Group 2- MTX+SSZ+HCQ | Any gastrointestinal adverse reaction | 16 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Group 1- MTX+LEF+HCQ | 68 | |
| Overall Study | STARTED | Group 2- MTX+SSZ+HCQ | 68 | |
| Overall Study | COMPLETED | Group 1- MTX+LEF+HCQ | 59 | |
| Overall Study | COMPLETED | Group 2- MTX+SSZ+HCQ | 61 | |
| Overall Study | NOT COMPLETED | Group 1- MTX+LEF+HCQ | 9 | |
| Overall Study | NOT COMPLETED | Group 2- MTX+SSZ+HCQ | 7 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastrointestinal adverse events | Gastrointestinal disorders | Group 1- MTX+LEF+HCQ | 11 | 68 | 11 |
| other | Gastrointestinal adverse events | Gastrointestinal disorders | Group 2- MTX+SSZ+HCQ | 16 | 68 | 16 |
| other | infections | Infections and infestations | Group 1- MTX+LEF+HCQ | 6 | 68 | 6 |
| other | infections | Infections and infestations | Group 2- MTX+SSZ+HCQ | 7 | 68 | 7 |
| other | hypertension | Cardiac disorders | Group 1- MTX+LEF+HCQ | 1 | 68 | 1 |
| other | hypertension | Cardiac disorders | Group 2- MTX+SSZ+HCQ | 0 | 68 | 0 |
| other | Hairfall | Skin and subcutaneous tissue disorders | Group 1- MTX+LEF+HCQ | 2 | 68 | 2 |
| other | Hairfall | Skin and subcutaneous tissue disorders | Group 2- MTX+SSZ+HCQ | 2 | 68 | 2 |
| other | Raised liver enzymes | Hepatobiliary disorders | Group 1- MTX+LEF+HCQ | 1 | 68 | 1 |
| other | Raised liver enzymes | Hepatobiliary disorders | Group 2- MTX+SSZ+HCQ | 1 | 68 | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Group 1- MTX+LEF+HCQ | 0 | 68 |
| Total, all-cause mortality | Group 2- MTX+SSZ+HCQ | 0 | 68 |
| Total, other adverse events | Group 1- MTX+LEF+HCQ | 15 | 68 |
| Total, other adverse events | Group 2- MTX+SSZ+HCQ | 21 | 68 |
| Total, serious adverse events | Group 1- MTX+LEF+HCQ | 0 | 68 |
| Total, serious adverse events | Group 2- MTX+SSZ+HCQ | 0 | 68 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 34586472 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Group 1- MTX+LEF+HCQ vs Group 2- MTX+SSZ+HCQ: Number of Patients Achieving Good EULAR Response at the End of 12 Weeks | Trial comparisons |
| Group 1- MTX+LEF+HCQ vs Group 2- MTX+SSZ+HCQ: deaths from any cause | Trial comparisons |
| Group 1- MTX+LEF+HCQ vs Group 2- MTX+SSZ+HCQ: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02930343
GET https://conductscience.org/api/trials/v1/NCT02930343/results?page=2