Rheumatoid Arthritis
Conditions
Brief summary
This multicenter study with a randomized, double-blind, parallel-group phase will evaluate the safety and efficacy of RoActemra/Actemra (tocilizumab) in combination with methotrexate versus RoActemra/Actemra monotherapy in patients with mild to moderate rheumatoid arthritis, with an inadequate response to methotrexate. Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks plus oral methotrexate 15-25 mg weekly for 12 weeks. Patients with a good/moderate EULAR response will then be randomized to receive either RoActemra/Actemra plus methotrexate or RoActemra/Actemra plus placebo for the following 12 weeks. Anticipated time on study treatment is 6 months.
Interventions
DRUGmethotrexate
15-25 mg orally weekly, Weeks 1-12
DRUGplacebo
methotrexate placebo orally weekly, Weeks 13-24
DRUGtocilizumab [RoActemra/Actemra]
8 mg/kg iv every 4 weeks, 24 weeks
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients, \>/= 18 years of age * Rheumatoid arthritis of \>/= 1 year duration * Mild to moderate disease activity at screening (DAS 28 \</= 4.5 and \>2.6) * On methotrexate treatment for at least 12 weeks, at stable oral dose of (10)15 mg to 25 mg/week for at least 6 weeks prior to Day 1 * Body weight \</= 150 kg * Oral corticosteroids must have been at stable dose (maximum 10 mg/day) for at least 25 out of 28 days prior to baseline
Exclusion criteria
* Major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months after baseline * Rheumatic autoimmune disease other than rheumatoid arthritis * Functional class IV American College of Rheumatology (ACR) Classification * Prior history of or current inflammatory joint disease other than rheumatoid arthritis * Treatment with a biologic agent at any time prior to baseline * Treatment with traditional DMARDs other than methotrexate within 1 month (for leflunomide 3 months) prior to baseline * Intraarticular or parenteral corticosteroids within 6 weeks prior to baseline * Previous treatment with tocilizumab * Pregnant or lactating women * Uncontrolled disease states, such as asthma, psoriasis or inflammatory bowel disease where flares are commonly treated with oral or parenteral corticosteroids * Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections * History of or currently active primary or secondary immunodeficiency * Evidence of active malignant disease, malignancies diagnosed within the previous 5 years * Active tuberculosis requiring treatment within the previous 3 years * Positive for HIV infection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Week 12 (Randomization) to Week 24 in DAS28 | Weeks 12 and 24 | The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 equals (=) \[0.56 multiplied by (\*) the square root (√) of TJC\] plus (+) \[0.28 \* √ of SJC\] + (0.70 \* the natural logarithm (ln) ESR in millimeters per hour (mm/h)\] + \[0.014 \* GH in mm visual analogue assessment (VAS)\]. A negative change from randomization indicated improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| vPercentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24 | Week 24 | The CDAI is a combined index for measuring disease activity in RA. CDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), as well as patient global assessment (PGA) and evaluator global assessment (EGA) of disease activity, both scored 0 to 10 centimeter (cm) as assessed by VAS. CDAI was calculated according to the following formula: CDAI = SJC + TJC + PGA + EGA. CDAI \< 2.8 = remission. |
| Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 24 | Week 24 | The SDAI is a combined index for measuring disease activity in RA. SDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), PGA and EGA of disease activity, both scored 0 to 10 cm as assessed by VAS, and C-reactive protein level (CRP) in milligrams per deciliter (mg/dL) where normal \< 1 mg/dL. CDAI was calculated according to the following formula: SDAI = TJC + SJC + PGA + EGA + CRP. SDAI \< 3.3 = remission. |
| Percentage of Participants With Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) Remission at Week 24 | Week 24 | The RADAI-5 is a combined index for measuring disease activity in RA. RADAI-5 is comprised of the following 5 questions: how active was your arthritis the last 6 months? (0 = completely inactive to 10 = extremely active); how active is your arthritis today with respect to joint tenderness and swelling? (0 = completely inactive to 10 = extremely active); how severe is your arthritis pain today? (0 = no pain to 10 = unbearable pain); how would you describe your general health today? (0 = very good to 10 = very bad); and did you experience joint (hand) stiffness on awakening yesterday morning? If yes, how long did this stiffness last? (0 = no stiffness to 10 = stiffness the whole day). RADAI was calculated according to the following formula: \[question (Q) 1 + Q2 + Q3 + Q4 + Q5\]/5. RADAI-5 from 0-1.4 = remission. |
| Percentage of Participants With DAS28 Remission at Week 24 | Week 24 | The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, both scored 0-28 (higher scores indicate higher disease activity, as well as APR determined as ESR, and GH, both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 = 0.56 \* √ of TJC + 0.28 \* √ of SJC + 0.70 \* ln ESR mm/hr + 0.014 \* GH in mm VAS. DAS28 \< 2.6 = remission. |
| Change From Week 12 (Randomization) to Week 24 in Short Form-36 Health Survey (SF-36) Score | Weeks 12 and 24 | SF-36 scores were obtained by scoring participants' responses to a 36-item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores. A negative change from randomization indicated improvement. |
| Change From Week 12 (Randomization) to Week 24 in Visual Analog Scales (VAS) Scores | Weeks 12 and 24 | VAS scores were obtained by scoring participants' disease activity as assessed on a 0-100 millimeter (mm) horizontal visual scale. The left-hand extreme of the line = 0 mm (no disease activity = symptom-free and no arthritis symptoms), and the right-hand extreme of the line = 100 mm (maximum disease activity). A negative change from randomization indicated improvement. |
| Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Week 24 | TSQM scores were obtained by scoring participants' responses to a 14-item questionnaire. TSQM evaluated 4 aspects of treatment satisfaction: effectiveness, side effects, convenience, and global satisfaction from a range of 0 to 100 percent (%), with 100% being the best possible result. |
| Change From Week 12 (Randomization) to Week 24 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | Weeks 12 and 24 | HAQ-DI scores were obtained by scoring participants' responses to a 20-item questionnaire. HAQ-DQ evaluated 8 domains of health: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities from a range of 0 (without any difficulty) to 3 (unable to do). The sum of scores was divided by the number of domains for a total score of 0 (best) to 3 (worst). A negative change from randomization indicated improvement. |
Countries
Austria
Participant flow
Pre-assignment details
The screening population consisted of men and women with mild-to-moderate active rheumatoid arthritis (RA). Pre-study methotrexate (MTX) administration for at least 12 weeks. Participants experiencing inadequate response to MTX (Disease Activity Score Based on 28 Joints Count \[DAS28\] 28 less than \[\<\] 4,5 and greater than \[\>\] 2,6) enrolled.
Participants by arm
| Arm | Count |
|---|---|
| Group A: TCZ + MTX During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24. | 32 |
| Group B: TCZ + Placebo During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24. | 33 |
| Total | 65 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 12-Week Open-Label Run-In Period | No EULAR Response | 4 | 0 | 0 |
| 12-Week Open-Label Run-In Period | Physician Decision | 7 | 0 | 0 |
| 12-Week Open-Label Run-In Period | Withdrawal by Subject | 1 | 0 | 0 |
| Randomized Study Treatment | Physician Decision | 0 | 0 | 1 |
| Randomized Study Treatment | Screening failure | 0 | 1 | 0 |
| Randomized Study Treatment | Withdrawal by Subject | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Group A: TCZ + MTX | Group B: TCZ + Placebo | Total |
|---|---|---|---|
| Age, Continuous | 57.78 years STANDARD_DEVIATION 11.88 | 57.15 years STANDARD_DEVIATION 10.83 | 57.46 years STANDARD_DEVIATION 11.28 |
| Sex: Female, Male Female | 26 Participants | 25 Participants | 51 Participants |
| Sex: Female, Male Male | 6 Participants | 8 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 14 / 32 | 12 / 33 |
| serious Total, serious adverse events | 2 / 32 | 5 / 33 |
Outcome results
Primary
Change From Week 12 (Randomization) to Week 24 in DAS28
The DAS28 is a combined index for measuring disease activity in rheumatoid arthritis (RA). The index includes swollen joint counts (SJC) and tender joint counts (TJC), both scored 0-28 (higher scores indicate higher disease activity), as well as acute phase response (APR) determined as erythrocyte sedimentation rate (ESR), and general health (GH), both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 equals (=) \[0.56 multiplied by (\*) the square root (√) of TJC\] plus (+) \[0.28 \* √ of SJC\] + (0.70 \* the natural logarithm (ln) ESR in millimeters per hour (mm/h)\] + \[0.014 \* GH in mm visual analogue assessment (VAS)\]. A negative change from randomization indicated improvement.
Time frame: Weeks 12 and 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: TCZ + MTX | Change From Week 12 (Randomization) to Week 24 in DAS28 | 0.17 score on a scale | Standard Deviation 0.83 |
| Group B: TCZ + Placebo | Change From Week 12 (Randomization) to Week 24 in DAS28 | -0.16 score on a scale | Standard Deviation 1.13 |
p-value: 0.18895% CI: [-0.165, 0.82]t-test, 2 sided
Comparison: At Week 12.p-value: 0.015ANCOVA
Comparison: Adjusted change in DAS28 score from Weeks 12-24.p-value: 0.304ANCOVA
Secondary
Change From Week 12 (Randomization) to Week 24 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score
HAQ-DI scores were obtained by scoring participants' responses to a 20-item questionnaire. HAQ-DQ evaluated 8 domains of health: dressing/grooming, arising, eating, walking, hygiene, reach, grip, and common daily activities from a range of 0 (without any difficulty) to 3 (unable to do). The sum of scores was divided by the number of domains for a total score of 0 (best) to 3 (worst). A negative change from randomization indicated improvement.
Time frame: Weeks 12 and 24
Population: ITT population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A: TCZ + MTX | Change From Week 12 (Randomization) to Week 24 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | 0.04 score on a scale | Standard Deviation 0.28 |
| Group B: TCZ + Placebo | Change From Week 12 (Randomization) to Week 24 in Health Assessment Questionnaire - Disability Index (HAQ-DI) Score | -0.06 score on a scale | Standard Deviation 0.4 |
p-value: 0.842Wilcoxon (Mann-Whitney)
Secondary
Change From Week 12 (Randomization) to Week 24 in Short Form-36 Health Survey (SF-36) Score
SF-36 scores were obtained by scoring participants' responses to a 36-item questionnaire. SF-36 evaluated 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, mental health from a range of 1 (better) to 5 (worst). The score for each section was an average of the individual question scores, which were scaled 0-100 (100=highest level of functioning). These 8 aspects were summarized as physical and mental component scores. A negative change from randomization indicated improvement.
Time frame: Weeks 12 and 24
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: TCZ + MTX | Change From Week 12 (Randomization) to Week 24 in Short Form-36 Health Survey (SF-36) Score | Physical standardized value | 0.89 score on a scale | Standard Deviation 10.48 |
| Group A: TCZ + MTX | Change From Week 12 (Randomization) to Week 24 in Short Form-36 Health Survey (SF-36) Score | Mental standardized value | -5.41 score on a scale | Standard Deviation 9.24 |
| Group B: TCZ + Placebo | Change From Week 12 (Randomization) to Week 24 in Short Form-36 Health Survey (SF-36) Score | Physical standardized value | 0.75 score on a scale | Standard Deviation 10.08 |
| Group B: TCZ + Placebo | Change From Week 12 (Randomization) to Week 24 in Short Form-36 Health Survey (SF-36) Score | Mental standardized value | -1.69 score on a scale | Standard Deviation 9.2 |
Comparison: Physical standardized valuep-value: 0.417Wilcoxon (Mann-Whitney)
Comparison: Mental standardized valuep-value: 0.112Wilcoxon (Mann-Whitney)
Secondary
Change From Week 12 (Randomization) to Week 24 in Visual Analog Scales (VAS) Scores
VAS scores were obtained by scoring participants' disease activity as assessed on a 0-100 millimeter (mm) horizontal visual scale. The left-hand extreme of the line = 0 mm (no disease activity = symptom-free and no arthritis symptoms), and the right-hand extreme of the line = 100 mm (maximum disease activity). A negative change from randomization indicated improvement.
Time frame: Weeks 12 and 24
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: TCZ + MTX | Change From Week 12 (Randomization) to Week 24 in Visual Analog Scales (VAS) Scores | Pain | 1.09 score on a scale | Standard Deviation 18.48 |
| Group A: TCZ + MTX | Change From Week 12 (Randomization) to Week 24 in Visual Analog Scales (VAS) Scores | Fatigue | 1.91 score on a scale | Standard Deviation 17.16 |
| Group B: TCZ + Placebo | Change From Week 12 (Randomization) to Week 24 in Visual Analog Scales (VAS) Scores | Pain | -2.88 score on a scale | Standard Deviation 22.04 |
| Group B: TCZ + Placebo | Change From Week 12 (Randomization) to Week 24 in Visual Analog Scales (VAS) Scores | Fatigue | -1.88 score on a scale | Standard Deviation 17.49 |
Comparison: Fatiguep-value: 0.655Wilcoxon (Mann-Whitney)
Comparison: Painp-value: 0.839Wilcoxon (Mann-Whitney)
Secondary
Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score
TSQM scores were obtained by scoring participants' responses to a 14-item questionnaire. TSQM evaluated 4 aspects of treatment satisfaction: effectiveness, side effects, convenience, and global satisfaction from a range of 0 to 100 percent (%), with 100% being the best possible result.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A: TCZ + MTX | Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Effectiveness | 72.41 score on a scale | Standard Deviation 34.85 |
| Group A: TCZ + MTX | Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Side-effects | 94.15 score on a scale | Standard Deviation 19.16 |
| Group A: TCZ + MTX | Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Convenience | 85.48 score on a scale | Standard Deviation 21.97 |
| Group A: TCZ + MTX | Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Global satisfaction | 86.64 score on a scale | Standard Deviation 21.09 |
| Group B: TCZ + Placebo | Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Global satisfaction | 86.36 score on a scale | Standard Deviation 13.53 |
| Group B: TCZ + Placebo | Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Effectiveness | 82.49 score on a scale | Standard Deviation 24.14 |
| Group B: TCZ + Placebo | Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Convenience | 86.03 score on a scale | Standard Deviation 15.6 |
| Group B: TCZ + Placebo | Participant Satisfaction With Treatment as Assessed by Treatment Satisfaction Questionnaire for Medication (TSQM) Score | Side-effects | 94.89 score on a scale | Standard Deviation 14.7 |
Comparison: Effectivenessp-value: 0.58Wilcoxon (Mann-Whitney)
Comparison: Side-effectsp-value: 0.975Wilcoxon (Mann-Whitney)
Comparison: Conveniencep-value: 0.421Wilcoxon (Mann-Whitney)
Comparison: Global satisfactionp-value: 0.277Wilcoxon (Mann-Whitney)
Secondary
Percentage of Participants With DAS28 Remission at Week 24
The DAS28 is a combined index for measuring disease activity in RA. The index includes SJC and TJC, both scored 0-28 (higher scores indicate higher disease activity, as well as APR determined as ESR, and GH, both scored 1-100 (higher scores indicate higher disease activity). DAS28 was calculated according to the following formula: DAS28 = 0.56 \* √ of TJC + 0.28 \* √ of SJC + 0.70 \* ln ESR mm/hr + 0.014 \* GH in mm VAS. DAS28 \< 2.6 = remission.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: TCZ + MTX | Percentage of Participants With DAS28 Remission at Week 24 | 81.25 percentage of participants |
| Group B: TCZ + Placebo | Percentage of Participants With DAS28 Remission at Week 24 | 87.50 percentage of participants |
p-value: 0.732Fisher Exact
Secondary
Percentage of Participants With Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) Remission at Week 24
The RADAI-5 is a combined index for measuring disease activity in RA. RADAI-5 is comprised of the following 5 questions: how active was your arthritis the last 6 months? (0 = completely inactive to 10 = extremely active); how active is your arthritis today with respect to joint tenderness and swelling? (0 = completely inactive to 10 = extremely active); how severe is your arthritis pain today? (0 = no pain to 10 = unbearable pain); how would you describe your general health today? (0 = very good to 10 = very bad); and did you experience joint (hand) stiffness on awakening yesterday morning? If yes, how long did this stiffness last? (0 = no stiffness to 10 = stiffness the whole day). RADAI was calculated according to the following formula: \[question (Q) 1 + Q2 + Q3 + Q4 + Q5\]/5. RADAI-5 from 0-1.4 = remission.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: TCZ + MTX | Percentage of Participants With Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) Remission at Week 24 | 32.26 percentage of participants |
| Group B: TCZ + Placebo | Percentage of Participants With Rheumatoid Arthritis Disease Activity Index-5 (RADAI-5) Remission at Week 24 | 54.55 percentage of participants |
p-value: 0.084Fisher Exact
Secondary
Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 24
The SDAI is a combined index for measuring disease activity in RA. SDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), PGA and EGA of disease activity, both scored 0 to 10 cm as assessed by VAS, and C-reactive protein level (CRP) in milligrams per deciliter (mg/dL) where normal \< 1 mg/dL. CDAI was calculated according to the following formula: SDAI = TJC + SJC + PGA + EGA + CRP. SDAI \< 3.3 = remission.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: TCZ + MTX | Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 24 | 40.63 percentage of participants |
| Group B: TCZ + Placebo | Percentage of Participants With Simplified Disease Activity Index (SDAI) Remission at Week 24 | 53.13 percentage of participants |
p-value: 0.453Fisher Exact
Secondary
vPercentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24
The CDAI is a combined index for measuring disease activity in RA. CDAI is the sum of TJC and SJC, both scored 0-28 (higher scores indicate higher disease activity), as well as patient global assessment (PGA) and evaluator global assessment (EGA) of disease activity, both scored 0 to 10 centimeter (cm) as assessed by VAS. CDAI was calculated according to the following formula: CDAI = SJC + TJC + PGA + EGA. CDAI \< 2.8 = remission.
Time frame: Week 24
Population: ITT population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group A: TCZ + MTX | vPercentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24 | 34.38 percentage of participants |
| Group B: TCZ + Placebo | vPercentage of Participants With Clinical Disease Activity Index (CDAI) Remission at Week 24 | 53.13 percentage of participants |
p-value: 0.207Fisher Exact