Trial Outcomes & Findings for Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial (NCT NCT03739853)
NCT ID: NCT03739853
Last Updated: 2025-11-26
Results Overview
A composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as \<3.2.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
192 participants
Primary outcome timeframe
24 weeks
Results posted on
2025-11-26
Participant Flow
Participant milestones
| Measure |
Standard Care
Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice following international recommendations and National requirements for the prescription of biologic therapy\[19-22\]. Commonly Initial therapy will be with methotrexate alone (15mg/week rising to 25mg/week as tolerated by week 8 of therapy) unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (most commonly sulfasalazine or leflunomide) added or switched to. In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.
Methotrexate: Used in all three arms of study
Sulfasalazine: Used in arm 2 of study
Leflunomide: Used in arm 2 of study
|
Combination csDMARD
Arm 2 - Combination DMARD arm. All participants will be prescribed methotrexate with an additional DMARD (either sulfasalazine or leflunomide) at baseline. Response will be assessed after 12 weeks of therapy using the Minimal Disease Activity (MDA) criteria. Participants who achieve the MDA criteria by week 12 on this combination therapy will continue . Participants who show a significant response by in week 12 (a reduction in tender and swollen joint counts of at least 20%) but do not yet meet the MDA criteria should continue on this therapy for an additional 12 weeks before review. Participants failing to show significant response (reduction in joint counts by less than 20%) by week 12 on this combination therapy or those failing to meet MDA criteria by week 24 will be eligible for rescue therapy
Methotrexate: Used in all three arms of study
Sulfasalazine: Used in arm 2 of study
Leflunomide: Used in arm 2 of study
|
Early TNF Inhibition
Early biologic arm. All participants will be prescribed methotrexate (given weekly) with a TNF inhibitor (adalimumab given every two weeks) at baseline. Treatment with TNF inhibitor will be continued until week 24 at which time the TNF inhibitor will be tapered to week 32. The TNF inhibitor will be stopped completely after week 32 and participants will continue on methotrexate. In case of flare of disease, participants will be eligible for rescue therapy
Methotrexate: Used in all three arms of study
Adalimumab: Used in arm 3 of the study only
|
|---|---|---|---|
|
Overall Study
STARTED
|
64
|
63
|
65
|
|
Overall Study
COMPLETED
|
58
|
60
|
62
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Standard Care
n=64 Participants
Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice following international recommendations and National requirements for the prescription of biologic therapy\[19-22\]. Commonly Initial therapy will be with methotrexate alone (15mg/week rising to 25mg/week as tolerated by week 8 of therapy) unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (most commonly sulfasalazine or leflunomide) added or switched to. In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.
Methotrexate: Used in all three arms of study
Sulfasalazine: Used in arm 2 of study
Leflunomide: Used in arm 2 of study
|
Combination csDMARD
n=63 Participants
Arm 2 - Combination DMARD arm. All participants will be prescribed methotrexate with an additional DMARD (either sulfasalazine or leflunomide) at baseline. Response will be assessed after 12 weeks of therapy using the Minimal Disease Activity (MDA) criteria. Participants who achieve the MDA criteria by week 12 on this combination therapy will continue . Participants who show a significant response by in week 12 (a reduction in tender and swollen joint counts of at least 20%) but do not yet meet the MDA criteria should continue on this therapy for an additional 12 weeks before review. Participants failing to show significant response (reduction in joint counts by less than 20%) by week 12 on this combination therapy or those failing to meet MDA criteria by week 24 will be eligible for rescue therapy
Methotrexate: Used in all three arms of study
Sulfasalazine: Used in arm 2 of study
Leflunomide: Used in arm 2 of study
|
Early TNF Inhibition
n=65 Participants
Early biologic arm. All participants will be prescribed methotrexate (given weekly) with a TNF inhibitor (adalimumab given every two weeks) at baseline. Treatment with TNF inhibitor will be continued until week 24 at which time the TNF inhibitor will be tapered to week 32. The TNF inhibitor will be stopped completely after week 32 and participants will continue on methotrexate. In case of flare of disease, participants will be eligible for rescue therapy
Methotrexate: Used in all three arms of study
Adalimumab: Used in arm 3 of the study only
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50 years
n=64 Participants
|
51 years
n=63 Participants
|
48 years
n=65 Participants
|
49 years
n=192 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=64 Participants
|
33 Participants
n=63 Participants
|
28 Participants
n=65 Participants
|
92 Participants
n=192 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=64 Participants
|
30 Participants
n=63 Participants
|
37 Participants
n=65 Participants
|
100 Participants
n=192 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
64 participants
n=64 Participants
|
63 participants
n=63 Participants
|
65 participants
n=65 Participants
|
192 participants
n=192 Participants
|
PRIMARY outcome
Timeframe: 24 weeksPopulation: With complete data
A composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as \<3.2.
Outcome measures
| Measure |
Standard Care
n=39 Participants
Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice following international recommendations and National requirements for the prescription of biologic therapy\[19-22\]. Commonly Initial therapy will be with methotrexate alone (15mg/week rising to 25mg/week as tolerated by week 8 of therapy) unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (most commonly sulfasalazine or leflunomide) added or switched to. In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.
Methotrexate: Used in all three arms of study
Sulfasalazine: Used in arm 2 of study
Leflunomide: Used in arm 2 of study
|
Combination csDMARD
n=47 Participants
Arm 2 - Combination DMARD arm. All participants will be prescribed methotrexate with an additional DMARD (either sulfasalazine or leflunomide) at baseline. Response will be assessed after 12 weeks of therapy using the Minimal Disease Activity (MDA) criteria. Participants who achieve the MDA criteria by week 12 on this combination therapy will continue . Participants who show a significant response by in week 12 (a reduction in tender and swollen joint counts of at least 20%) but do not yet meet the MDA criteria should continue on this therapy for an additional 12 weeks before review. Participants failing to show significant response (reduction in joint counts by less than 20%) by week 12 on this combination therapy or those failing to meet MDA criteria by week 24 will be eligible for rescue therapy
Methotrexate: Used in all three arms of study
Sulfasalazine: Used in arm 2 of study
Leflunomide: Used in arm 2 of study
|
Early TNF Inhibition
n=53 Participants
Early biologic arm. All participants will be prescribed methotrexate (given weekly) with a TNF inhibitor (adalimumab given every two weeks) at baseline. Treatment with TNF inhibitor will be continued until week 24 at which time the TNF inhibitor will be tapered to week 32. The TNF inhibitor will be stopped completely after week 32 and participants will continue on methotrexate. In case of flare of disease, participants will be eligible for rescue therapy
Methotrexate: Used in all three arms of study
Adalimumab: Used in arm 3 of the study only
|
|---|---|---|---|
|
Psoriatic Arthritis Disease Activity Score (PASDAS)
|
4.7 score on a scale
Standard Deviation 1.5
|
4.0 score on a scale
Standard Deviation 1.5
|
3.6 score on a scale
Standard Deviation 1.9
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: with complete data
A composite measure of PsA disease activity. This score is a composite measure of disease activity in PsA. There is only one total score which ranges from 0-10 with higher numbers indicating more active disease. Low disease activity is defined as \<3.2.
Outcome measures
| Measure |
Standard Care
n=45 Participants
Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice following international recommendations and National requirements for the prescription of biologic therapy\[19-22\]. Commonly Initial therapy will be with methotrexate alone (15mg/week rising to 25mg/week as tolerated by week 8 of therapy) unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (most commonly sulfasalazine or leflunomide) added or switched to. In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.
Methotrexate: Used in all three arms of study
Sulfasalazine: Used in arm 2 of study
Leflunomide: Used in arm 2 of study
|
Combination csDMARD
n=45 Participants
Arm 2 - Combination DMARD arm. All participants will be prescribed methotrexate with an additional DMARD (either sulfasalazine or leflunomide) at baseline. Response will be assessed after 12 weeks of therapy using the Minimal Disease Activity (MDA) criteria. Participants who achieve the MDA criteria by week 12 on this combination therapy will continue . Participants who show a significant response by in week 12 (a reduction in tender and swollen joint counts of at least 20%) but do not yet meet the MDA criteria should continue on this therapy for an additional 12 weeks before review. Participants failing to show significant response (reduction in joint counts by less than 20%) by week 12 on this combination therapy or those failing to meet MDA criteria by week 24 will be eligible for rescue therapy
Methotrexate: Used in all three arms of study
Sulfasalazine: Used in arm 2 of study
Leflunomide: Used in arm 2 of study
|
Early TNF Inhibition
n=49 Participants
Early biologic arm. All participants will be prescribed methotrexate (given weekly) with a TNF inhibitor (adalimumab given every two weeks) at baseline. Treatment with TNF inhibitor will be continued until week 24 at which time the TNF inhibitor will be tapered to week 32. The TNF inhibitor will be stopped completely after week 32 and participants will continue on methotrexate. In case of flare of disease, participants will be eligible for rescue therapy
Methotrexate: Used in all three arms of study
Adalimumab: Used in arm 3 of the study only
|
|---|---|---|---|
|
Psoriatic Arthritis Disease Activity Score (PASDAS)
|
4.1 score on a scale
Standard Deviation 1.8
|
3.8 score on a scale
Standard Deviation 1.5
|
3.5 score on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: 12, 24, 36, 48 weeksPopulation: Enrolled in study
Response will be assessed after 12 weeks of therapy using the Minimal Disease Activity (MDA) criteria. These assess 7 different outcomes and patients should meet at least 5 of the 7 items to be classified as being in MDA. The MDA criteria are shown in the box below: Outcome Measure (see Section 8) Score +1 for each outcome measure which is below the value below. Total score of ≥5 indicates MDA achieved Tender joint count (TJC) (using 68 joint count) ≤1 Swollen joint count (SJC) (using 66 joint count) ≤1 Enthesitis count (using LEI or SPARCC) ≤1 Skin assessment PASI≤1 or BSA≤3% Patient global VAS (mm) ≤20 Patient pain VAS (mm) ≤15 HAQ ≤0.5
Outcome measures
| Measure |
Standard Care
n=64 Participants
Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice following international recommendations and National requirements for the prescription of biologic therapy\[19-22\]. Commonly Initial therapy will be with methotrexate alone (15mg/week rising to 25mg/week as tolerated by week 8 of therapy) unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (most commonly sulfasalazine or leflunomide) added or switched to. In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.
Methotrexate: Used in all three arms of study
Sulfasalazine: Used in arm 2 of study
Leflunomide: Used in arm 2 of study
|
Combination csDMARD
n=63 Participants
Arm 2 - Combination DMARD arm. All participants will be prescribed methotrexate with an additional DMARD (either sulfasalazine or leflunomide) at baseline. Response will be assessed after 12 weeks of therapy using the Minimal Disease Activity (MDA) criteria. Participants who achieve the MDA criteria by week 12 on this combination therapy will continue . Participants who show a significant response by in week 12 (a reduction in tender and swollen joint counts of at least 20%) but do not yet meet the MDA criteria should continue on this therapy for an additional 12 weeks before review. Participants failing to show significant response (reduction in joint counts by less than 20%) by week 12 on this combination therapy or those failing to meet MDA criteria by week 24 will be eligible for rescue therapy
Methotrexate: Used in all three arms of study
Sulfasalazine: Used in arm 2 of study
Leflunomide: Used in arm 2 of study
|
Early TNF Inhibition
n=65 Participants
Early biologic arm. All participants will be prescribed methotrexate (given weekly) with a TNF inhibitor (adalimumab given every two weeks) at baseline. Treatment with TNF inhibitor will be continued until week 24 at which time the TNF inhibitor will be tapered to week 32. The TNF inhibitor will be stopped completely after week 32 and participants will continue on methotrexate. In case of flare of disease, participants will be eligible for rescue therapy
Methotrexate: Used in all three arms of study
Adalimumab: Used in arm 3 of the study only
|
|---|---|---|---|
|
Minimal Disease Activity (MDA)
Week 12
|
44 Participants
|
40 Participants
|
42 Participants
|
|
Minimal Disease Activity (MDA)
Week 24
|
38 Participants
|
36 Participants
|
36 Participants
|
|
Minimal Disease Activity (MDA)
Week 36
|
30 Participants
|
23 Participants
|
30 Participants
|
|
Minimal Disease Activity (MDA)
Week 48
|
33 Participants
|
33 Participants
|
35 Participants
|
SECONDARY outcome
Timeframe: 12, 24, 36, 48 weeksPopulation: ITT
A questionnaire assessing the overall impact of disease on a patient. This is a scale of 12 questions (scored 0-10) which are combined with published weighting scales to one final 0-10 score where 0 is "no impact" and 10 is "maximal impact". There are no subscales. Patient acceptable symptom state is \<=4.
Outcome measures
| Measure |
Standard Care
n=64 Participants
Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice following international recommendations and National requirements for the prescription of biologic therapy\[19-22\]. Commonly Initial therapy will be with methotrexate alone (15mg/week rising to 25mg/week as tolerated by week 8 of therapy) unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (most commonly sulfasalazine or leflunomide) added or switched to. In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.
Methotrexate: Used in all three arms of study
Sulfasalazine: Used in arm 2 of study
Leflunomide: Used in arm 2 of study
|
Combination csDMARD
n=63 Participants
Arm 2 - Combination DMARD arm. All participants will be prescribed methotrexate with an additional DMARD (either sulfasalazine or leflunomide) at baseline. Response will be assessed after 12 weeks of therapy using the Minimal Disease Activity (MDA) criteria. Participants who achieve the MDA criteria by week 12 on this combination therapy will continue . Participants who show a significant response by in week 12 (a reduction in tender and swollen joint counts of at least 20%) but do not yet meet the MDA criteria should continue on this therapy for an additional 12 weeks before review. Participants failing to show significant response (reduction in joint counts by less than 20%) by week 12 on this combination therapy or those failing to meet MDA criteria by week 24 will be eligible for rescue therapy
Methotrexate: Used in all three arms of study
Sulfasalazine: Used in arm 2 of study
Leflunomide: Used in arm 2 of study
|
Early TNF Inhibition
n=65 Participants
Early biologic arm. All participants will be prescribed methotrexate (given weekly) with a TNF inhibitor (adalimumab given every two weeks) at baseline. Treatment with TNF inhibitor will be continued until week 24 at which time the TNF inhibitor will be tapered to week 32. The TNF inhibitor will be stopped completely after week 32 and participants will continue on methotrexate. In case of flare of disease, participants will be eligible for rescue therapy
Methotrexate: Used in all three arms of study
Adalimumab: Used in arm 3 of the study only
|
|---|---|---|---|
|
Psoriatic Arthritis Impact of Disease (PsAID)
Week 12
|
3.9 score on a scale
Standard Error 2.2
|
4.4 score on a scale
Standard Error 2.7
|
3.5 score on a scale
Standard Error 2.3
|
|
Psoriatic Arthritis Impact of Disease (PsAID)
Week 24
|
3.8 score on a scale
Standard Error 2.1
|
3.5 score on a scale
Standard Error 2.4
|
3.1 score on a scale
Standard Error 2.5
|
|
Psoriatic Arthritis Impact of Disease (PsAID)
Week 36
|
3.2 score on a scale
Standard Error 2.1
|
2.9 score on a scale
Standard Error 2.4
|
3.3 score on a scale
Standard Error 2.3
|
|
Psoriatic Arthritis Impact of Disease (PsAID)
Week 48
|
3.4 score on a scale
Standard Error 2.5
|
3.3 score on a scale
Standard Error 2.6
|
3.0 score on a scale
Standard Error 2.5
|
Adverse Events
Standard Care
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Combination csDMARD
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Early TNF Inhibition
Serious events: 2 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Standard Care
n=64 participants at risk
Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice following international recommendations and National requirements for the prescription of biologic therapy\[19-22\]. Commonly Initial therapy will be with methotrexate alone (15mg/week rising to 25mg/week as tolerated by week 8 of therapy) unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (most commonly sulfasalazine or leflunomide) added or switched to. In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.
Methotrexate: Used in all three arms of study
Sulfasalazine: Used in arm 2 of study
Leflunomide: Used in arm 2 of study
|
Combination csDMARD
n=63 participants at risk
Arm 2 - Combination DMARD arm. All participants will be prescribed methotrexate with an additional DMARD (either sulfasalazine or leflunomide) at baseline. Response will be assessed after 12 weeks of therapy using the Minimal Disease Activity (MDA) criteria. Participants who achieve the MDA criteria by week 12 on this combination therapy will continue . Participants who show a significant response by in week 12 (a reduction in tender and swollen joint counts of at least 20%) but do not yet meet the MDA criteria should continue on this therapy for an additional 12 weeks before review. Participants failing to show significant response (reduction in joint counts by less than 20%) by week 12 on this combination therapy or those failing to meet MDA criteria by week 24 will be eligible for rescue therapy
Methotrexate: Used in all three arms of study
Sulfasalazine: Used in arm 2 of study
Leflunomide: Used in arm 2 of study
|
Early TNF Inhibition
n=65 participants at risk
Early biologic arm. All participants will be prescribed methotrexate (given weekly) with a TNF inhibitor (adalimumab given every two weeks) at baseline. Treatment with TNF inhibitor will be continued until week 24 at which time the TNF inhibitor will be tapered to week 32. The TNF inhibitor will be stopped completely after week 32 and participants will continue on methotrexate. In case of flare of disease, participants will be eligible for rescue therapy
Methotrexate: Used in all three arms of study
Adalimumab: Used in arm 3 of the study only
|
|---|---|---|---|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/64 • 48 weeks
|
0.00%
0/63 • 48 weeks
|
1.5%
1/65 • Number of events 1 • 48 weeks
|
|
Nervous system disorders
Cerebrovascualr haemorrhage
|
1.6%
1/64 • Number of events 1 • 48 weeks
|
0.00%
0/63 • 48 weeks
|
0.00%
0/65 • 48 weeks
|
|
Infections and infestations
perineal abscess
|
1.6%
1/64 • Number of events 1 • 48 weeks
|
0.00%
0/63 • 48 weeks
|
0.00%
0/65 • 48 weeks
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/64 • 48 weeks
|
0.00%
0/63 • 48 weeks
|
1.5%
1/65 • Number of events 1 • 48 weeks
|
Other adverse events
| Measure |
Standard Care
n=64 participants at risk
Control 'step-up' therapy in the cohort (MONITOR-PsA study). Therapy for the cohort is defined by standard NHS practice following international recommendations and National requirements for the prescription of biologic therapy\[19-22\]. Commonly Initial therapy will be with methotrexate alone (15mg/week rising to 25mg/week as tolerated by week 8 of therapy) unless this is contraindicated. In cases of non-response or intolerance to methotrexate, participants will have an alternative DMARD (most commonly sulfasalazine or leflunomide) added or switched to. In cases of failure of two DMARDs, treatment can be escalated to biologic therapy as per National Institute for Health and Clinical Excellence (NICE) recommendations. If the requisite disease activity is not met or if there are contraindications to biologics, alternative DMARD combinations will be used.
Methotrexate: Used in all three arms of study
Sulfasalazine: Used in arm 2 of study
Leflunomide: Used in arm 2 of study
|
Combination csDMARD
n=63 participants at risk
Arm 2 - Combination DMARD arm. All participants will be prescribed methotrexate with an additional DMARD (either sulfasalazine or leflunomide) at baseline. Response will be assessed after 12 weeks of therapy using the Minimal Disease Activity (MDA) criteria. Participants who achieve the MDA criteria by week 12 on this combination therapy will continue . Participants who show a significant response by in week 12 (a reduction in tender and swollen joint counts of at least 20%) but do not yet meet the MDA criteria should continue on this therapy for an additional 12 weeks before review. Participants failing to show significant response (reduction in joint counts by less than 20%) by week 12 on this combination therapy or those failing to meet MDA criteria by week 24 will be eligible for rescue therapy
Methotrexate: Used in all three arms of study
Sulfasalazine: Used in arm 2 of study
Leflunomide: Used in arm 2 of study
|
Early TNF Inhibition
n=65 participants at risk
Early biologic arm. All participants will be prescribed methotrexate (given weekly) with a TNF inhibitor (adalimumab given every two weeks) at baseline. Treatment with TNF inhibitor will be continued until week 24 at which time the TNF inhibitor will be tapered to week 32. The TNF inhibitor will be stopped completely after week 32 and participants will continue on methotrexate. In case of flare of disease, participants will be eligible for rescue therapy
Methotrexate: Used in all three arms of study
Adalimumab: Used in arm 3 of the study only
|
|---|---|---|---|
|
Nervous system disorders
Headache
|
14.1%
9/64 • Number of events 9 • 48 weeks
|
17.5%
11/63 • Number of events 11 • 48 weeks
|
7.7%
5/65 • Number of events 5 • 48 weeks
|
|
Gastrointestinal disorders
Nausea
|
29.7%
19/64 • Number of events 19 • 48 weeks
|
31.7%
20/63 • Number of events 20 • 48 weeks
|
23.1%
15/65 • Number of events 15 • 48 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
9.4%
6/64 • Number of events 6 • 48 weeks
|
12.7%
8/63 • Number of events 8 • 48 weeks
|
9.2%
6/65 • Number of events 6 • 48 weeks
|
|
Hepatobiliary disorders
Liver function test abnormalities
|
17.2%
11/64 • Number of events 11 • 48 weeks
|
30.2%
19/63 • Number of events 19 • 48 weeks
|
27.7%
18/65 • Number of events 18 • 48 weeks
|
|
Infections and infestations
Infection
|
4.7%
3/64 • Number of events 3 • 48 weeks
|
4.8%
3/63 • Number of events 3 • 48 weeks
|
9.2%
6/65 • Number of events 6 • 48 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place