Trial · NCT03739853

Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial

NCT03739853, Phase 4, Completed, University of Oxford; results first posted 2025-11-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial. Trials, record NCT03739853. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03739853

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Severe Psoriatic Arthritis - Early intervEntion to Control Disease: the SPEED Trial
NCT number: NCT03739853
Status: Completed
Phases: Phase 4
Enrollment: 192 participants, actual
Lead sponsor: University of Oxford
Conditions: Psoriatic Arthritis
Interventions: Methotrexate, Sulfasalazine, Leflunomide, Adalimumab
First posted: 2018-11-14
Last updated: 2025-11-26
Results first posted: 2025-11-26
Limitations and caveats: Some missing data in primary and secondary outcomes due to COVID and other missed visits

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Psoriatic Arthritis Disease Activity Score (PASDAS)	24 weeks	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.
Secondary	Psoriatic Arthritis Disease Activity Score (PASDAS)	48 weeks	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.
Secondary	Minimal Disease Activity (MDA)	12, 24, 36, 48 weeks	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
Secondary	Psoriatic Arthritis Impact of Disease (PsAID)	12, 24, 36, 48 weeks	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.

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	Psoriatic Arthritis Disease Activity Score (PASDAS)	24 weeks	With complete data	score on a scale	MEAN
SECONDARY	Psoriatic Arthritis Disease Activity Score (PASDAS)	48 weeks	with complete data	score on a scale	MEAN
SECONDARY	Minimal Disease Activity (MDA)	12, 24, 36, 48 weeks	Enrolled in study	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Psoriatic Arthritis Impact of Disease (PsAID)	12, 24, 36, 48 weeks	ITT	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group30

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Psoriatic Arthritis Disease Activity Score (PASDAS)	Standard Care		4.7	Standard Deviation 1.5	score on a scale
Psoriatic Arthritis Disease Activity Score (PASDAS)	Combination csDMARD		4.0	Standard Deviation 1.5	score on a scale
Psoriatic Arthritis Disease Activity Score (PASDAS)	Early TNF Inhibition		3.6	Standard Deviation 1.9	score on a scale
Psoriatic Arthritis Disease Activity Score (PASDAS)	Standard Care		4.1	Standard Deviation 1.8	score on a scale
Psoriatic Arthritis Disease Activity Score (PASDAS)	Combination csDMARD		3.8	Standard Deviation 1.5	score on a scale
Psoriatic Arthritis Disease Activity Score (PASDAS)	Early TNF Inhibition		3.5	Standard Deviation 1.7	score on a scale
Minimal Disease Activity (MDA)	Standard Care	Week 12	44		Participants
Minimal Disease Activity (MDA)	Combination csDMARD	Week 12	40		Participants
Minimal Disease Activity (MDA)	Early TNF Inhibition	Week 12	42		Participants
Minimal Disease Activity (MDA)	Standard Care	Week 24	38		Participants

1 to 10 of 30Source ClinicalTrials.gov

See all 30 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Standard Care	64
Overall Study	STARTED	Combination csDMARD	63
Overall Study	STARTED	Early TNF Inhibition	65
Overall Study	COMPLETED	Standard Care	58
Overall Study	COMPLETED	Combination csDMARD	60
Overall Study	COMPLETED	Early TNF Inhibition	62
Overall Study	NOT COMPLETED	Standard Care	6
Overall Study	NOT COMPLETED	Combination csDMARD	3
Overall Study	NOT COMPLETED	Early TNF Inhibition	3

Source ClinicalTrials.gov

Adverse events27

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	Headache	Nervous system disorders	Standard Care	9	64	9
other	Headache	Nervous system disorders	Combination csDMARD	11	63	11
other	Headache	Nervous system disorders	Early TNF Inhibition	5	65	5
other	Nausea	Gastrointestinal disorders	Standard Care	19	64	19
other	Nausea	Gastrointestinal disorders	Combination csDMARD	20	63	20
other	Nausea	Gastrointestinal disorders	Early TNF Inhibition	15	65	15
other	Diarrhoea	Gastrointestinal disorders	Standard Care	6	64	6
other	Diarrhoea	Gastrointestinal disorders	Combination csDMARD	8	63	8
other	Diarrhoea	Gastrointestinal disorders	Early TNF Inhibition	6	65	6
other	Liver function test abnormalities	Hepatobiliary disorders	Standard Care	11	64	11

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Standard Care	0	64
Total, all-cause mortality	Combination csDMARD	0	63
Total, all-cause mortality	Early TNF Inhibition	0	65
Total, other adverse events	Standard Care	19	64
Total, other adverse events	Combination csDMARD	20	63
Total, other adverse events	Early TNF Inhibition	18	65
Total, serious adverse events	Standard Care	2	64
Total, serious adverse events	Combination csDMARD	0	63
Total, serious adverse events	Early TNF Inhibition	2	65

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
38826570	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 comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03739853

GET https://conductscience.org/api/trials/v1/NCT03739853/results?page=2

API reference For AI assistants