Trial Outcomes & Findings for Comparison of Disease Modifying Antirheumatic Drugs Therapy in Patients With RA Failing Methotrexate Monotherapy (NCT NCT02930343)
NCT ID: NCT02930343
Last Updated: 2021-07-27
Results Overview
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
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
136 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-07-27
Participant Flow
patients were enrolled from OPD (outdoor patient department) of Rheumatology clinic of JIPMER , from September 2016 to March 2018
Participant milestones
| Measure |
Group 1- MTX+LEF+HCQ
Active Comparator: Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.
Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
Leflunomide: Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease
Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
|
Group 2- MTX+SSZ+HCQ
Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.
Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF)
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
68
|
|
Overall Study
COMPLETED
|
59
|
61
|
|
Overall Study
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
| Measure |
Group 1- MTX+LEF+HCQ
Active Comparator: Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.
Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
Leflunomide: Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease
Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
|
Group 2- MTX+SSZ+HCQ
Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.
Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Group 1- MTX+LEF+HCQ
n=68 Participants
Active Comparator: Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.
Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
Leflunomide: Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease
Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
|
Group 2- MTX+SSZ+HCQ
n=68 Participants
Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.
Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF)
|
Total
n=136 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age (years)
|
39 years
n=68 Participants
|
42 years
n=68 Participants
|
40 years
n=136 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=68 Participants
|
64 Participants
n=68 Participants
|
128 Participants
n=136 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=68 Participants
|
4 Participants
n=68 Participants
|
8 Participants
n=136 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Disease duration (months)
|
12 months
n=68 Participants
|
18 months
n=68 Participants
|
15 months
n=136 Participants
|
|
Rheumatoid factor positivity
|
51 Participants
n=68 Participants
|
44 Participants
n=68 Participants
|
95 Participants
n=136 Participants
|
|
Anti- cyclic citrullinated peptide antibody
|
51 Participants
n=68 Participants
|
54 Participants
n=68 Participants
|
105 Participants
n=136 Participants
|
|
DAS28ESR
|
4.3 units on a scale
n=68 Participants
|
4.2 units on a scale
n=68 Participants
|
4.2 units on a scale
n=136 Participants
|
|
Tender joint count (TJ28)
|
4 tender joints
n=68 Participants
|
4 tender joints
n=68 Participants
|
4 tender joints
n=136 Participants
|
|
Swollen joint count (SJ28)
|
2 swollen joints
n=68 Participants
|
2 swollen joints
n=68 Participants
|
2 swollen joints
n=136 Participants
|
|
Baseline ESR (mm at the end of 1 hour)
|
45 millimeter (mm)
n=68 Participants
|
40 millimeter (mm)
n=68 Participants
|
45 millimeter (mm)
n=136 Participants
|
|
Early morning stiffness (EMS) (minutes)
|
60 minutes
n=68 Participants
|
60 minutes
n=68 Participants
|
60 minutes
n=136 Participants
|
|
patient VAS global health
|
20 units on a scale
n=68 Participants
|
20 units on a scale
n=68 Participants
|
20 units on a scale
n=136 Participants
|
|
Indian Health assessment questionnaire
|
1.9 units on a scale
n=68 Participants
|
1.75 units on a scale
n=68 Participants
|
1.8 units on a scale
n=136 Participants
|
|
Ultrasound7 score (US7 score)
|
3.5 units on a scale
n=68 Participants
|
4 units on a scale
n=68 Participants
|
4 units on a scale
n=136 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Analysis was done by intention to treat
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
Outcome measures
| Measure |
Group 1- MTX+LEF+HCQ
n=68 Participants
Active Comparator: Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.
Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
Leflunomide: Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease
Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
|
Group 2- MTX+SSZ+HCQ
n=68 Participants
Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.
Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF)
|
|---|---|---|
|
Number of Patients Achieving Good EULAR Response at the End of 12 Weeks
|
40 participants
|
37 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: intention to treat analysis
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
Outcome measures
| Measure |
Group 1- MTX+LEF+HCQ
n=68 Participants
Active Comparator: Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.
Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
Leflunomide: Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease
Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
|
Group 2- MTX+SSZ+HCQ
n=68 Participants
Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.
Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF)
|
|---|---|---|
|
Disease Activity as Per Ultrasound-7 (US-7) Score
|
3.5 units on a scale
Interval 0.0 to 6.0
|
4 units on a scale
Interval 0.0 to 4.5
|
SECONDARY outcome
Timeframe: 24 weeksInfections, transaminitis, nausea, vomiting, derranged renal function tests etc
Outcome measures
| Measure |
Group 1- MTX+LEF+HCQ
n=68 Participants
Active Comparator: Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.
Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
Leflunomide: Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease
Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
|
Group 2- MTX+SSZ+HCQ
n=68 Participants
Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.
Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF)
|
|---|---|---|
|
Number of Participants With Adverse Drug Reactions
Total number of any adverse events
|
15 Participants
|
21 Participants
|
|
Number of Participants With Adverse Drug Reactions
Serious adverse events
|
0 Participants
|
0 Participants
|
|
Number of Participants With Adverse Drug Reactions
Any gastrointestinal adverse reaction
|
11 Participants
|
16 Participants
|
|
Number of Participants With Adverse Drug Reactions
Nausea
|
4 Participants
|
6 Participants
|
|
Number of Participants With Adverse Drug Reactions
Diarrhea
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Drug Reactions
Switch to parenteral Methotrexate
|
5 Participants
|
14 Participants
|
|
Number of Participants With Adverse Drug Reactions
Raised liver enzymes > 2 times upper limit normal
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Drug Reactions
Herpes labialis
|
0 Participants
|
2 Participants
|
|
Number of Participants With Adverse Drug Reactions
upper respiratory tract infection
|
5 Participants
|
5 Participants
|
|
Number of Participants With Adverse Drug Reactions
urinary tract infection
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Drug Reactions
Hypertension
|
1 Participants
|
0 Participants
|
|
Number of Participants With Adverse Drug Reactions
hairfall
|
2 Participants
|
2 Participants
|
|
Number of Participants With Adverse Drug Reactions
Cytopenia
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 weeksIndian 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
Outcome measures
| Measure |
Group 1- MTX+LEF+HCQ
n=68 Participants
Active Comparator: Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.
Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
Leflunomide: Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease
Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
|
Group 2- MTX+SSZ+HCQ
n=68 Participants
Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.
Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF)
|
|---|---|---|
|
Indian Health Assessment Questionnaire (iHAQ)
|
0.7 score on a scale
Interval 0.4 to 1.0
|
0.5 score on a scale
Interval 0.07 to 1.3
|
Adverse Events
Group 1- MTX+LEF+HCQ
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group 2- MTX+SSZ+HCQ
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1- MTX+LEF+HCQ
n=68 participants at risk
Active Comparator: Combination of Methotrexate (up to 25 mg per week), Leflunomide (20 mg once a day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.
Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
Leflunomide: Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease
Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
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Group 2- MTX+SSZ+HCQ
n=68 participants at risk
Combination of Methotrexate (up to 25 mg per week), Sulfasalazine (2g per day) and Hydroxychloroquine (200-400 mg once at night). All drugs are to be taken orally. Duration of therapy is for 3 months. All patients will receive folic acid (5 mg twice a week) along with methotrexate. Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop) will be given as bridging therapy.
Methotrexate: Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
Hydroxychloroquine: Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
Prednisolone: Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
Folic Acid: Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
Sulfasalazine: 5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF)
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Gastrointestinal disorders
Gastrointestinal adverse events
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16.2%
11/68 • Number of events 11 • 24 weeks
Adverse events were assessed for at each patient visit (clinical assessment and laboratory reports). Also, patients were given the contact number of researcher so that they can contact in case of any adverse reaction.
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23.5%
16/68 • Number of events 16 • 24 weeks
Adverse events were assessed for at each patient visit (clinical assessment and laboratory reports). Also, patients were given the contact number of researcher so that they can contact in case of any adverse reaction.
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Infections and infestations
infections
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8.8%
6/68 • Number of events 6 • 24 weeks
Adverse events were assessed for at each patient visit (clinical assessment and laboratory reports). Also, patients were given the contact number of researcher so that they can contact in case of any adverse reaction.
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10.3%
7/68 • Number of events 7 • 24 weeks
Adverse events were assessed for at each patient visit (clinical assessment and laboratory reports). Also, patients were given the contact number of researcher so that they can contact in case of any adverse reaction.
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Cardiac disorders
hypertension
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1.5%
1/68 • Number of events 1 • 24 weeks
Adverse events were assessed for at each patient visit (clinical assessment and laboratory reports). Also, patients were given the contact number of researcher so that they can contact in case of any adverse reaction.
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0.00%
0/68 • 24 weeks
Adverse events were assessed for at each patient visit (clinical assessment and laboratory reports). Also, patients were given the contact number of researcher so that they can contact in case of any adverse reaction.
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Skin and subcutaneous tissue disorders
Hairfall
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2.9%
2/68 • Number of events 2 • 24 weeks
Adverse events were assessed for at each patient visit (clinical assessment and laboratory reports). Also, patients were given the contact number of researcher so that they can contact in case of any adverse reaction.
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2.9%
2/68 • Number of events 2 • 24 weeks
Adverse events were assessed for at each patient visit (clinical assessment and laboratory reports). Also, patients were given the contact number of researcher so that they can contact in case of any adverse reaction.
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Hepatobiliary disorders
Raised liver enzymes
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1.5%
1/68 • Number of events 1 • 24 weeks
Adverse events were assessed for at each patient visit (clinical assessment and laboratory reports). Also, patients were given the contact number of researcher so that they can contact in case of any adverse reaction.
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1.5%
1/68 • Number of events 1 • 24 weeks
Adverse events were assessed for at each patient visit (clinical assessment and laboratory reports). Also, patients were given the contact number of researcher so that they can contact in case of any adverse reaction.
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Product Issues
Switch to parenteral Methotrexate
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7.4%
5/68 • Number of events 5 • 24 weeks
Adverse events were assessed for at each patient visit (clinical assessment and laboratory reports). Also, patients were given the contact number of researcher so that they can contact in case of any adverse reaction.
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20.6%
14/68 • Number of events 14 • 24 weeks
Adverse events were assessed for at each patient visit (clinical assessment and laboratory reports). Also, patients were given the contact number of researcher so that they can contact in case of any adverse reaction.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place