Trial · NCT01172639

Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.

NCT01172639, Phase 4, Completed, P. Verschueren; results first posted 2018-12-10

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis. Trials, record NCT01172639. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01172639

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Trial

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

Title: Effectiveness in Daily Practice of Different Treatment Strategies for Early Rheumatoid Arthritis.
NCT number: NCT01172639
Status: Completed
Phases: Phase 4
Enrollment: 400 participants, actual
Lead sponsor: P. Verschueren
Conditions: Rheumatoid Arthritis
Interventions: Methotrexate, Sulfasalazine, Leflunomide, Prednisone
First posted: 2010-07-30
Last updated: 2019-01-22
Other registries' IDs: eudract:2008-007225-39
Results first posted: 2018-12-10

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Remission According to DAS28-CRP at Week 16	week 16	Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 16. DAS28-CRP is calculated with the following formula : 0.56\SQRT TJC28+0.28\SQRT SJC28+0.36\ln (CRP+1)+0.014\GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS). A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity.
Primary	Remission According to DAS28-CRP at Week 52	week 52	Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 52. (co-primary end point) DAS28-CRP is calculated with the following formula : 0.56\SQRT TJC28+0.28\SQRT SJC28+0.36\ln (CRP+1)+0.014\GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS). A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity.
Primary	Remission According to DAS28-CRP at Week 104	week 104	Number of patients in remission according to DAS28-CRP (Disease Activity Score based on 28 joint count and C-reactive Protein) at week 104. (co-primary endpoints) DAS28-CRP is calculated with the following formula : 0.56\SQRT TJC28+0.28\SQRT SJC28+0.36\ln (CRP+1)+0.014\GH+0.96 in which TJC is the tender joint count, SJC the Swollen Joint Count and GH the general health estimated by the patient on a Visual Analogue Scale (VAS). A value below 2.6 is indicating remission, below or equal to 3.2 low disease activity, between 3.2 and 5.1 moderate disease activity and above 5.1 high disease activity.
Secondary	Remission According to SDAI (Simple Disease Activity Index) at Week 16	week 16	Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 16. SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS. A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity.
Secondary	Remission According to SDAI at Week 52	week 52	Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 52. SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS. A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity.
Secondary	Remission According to SDAI at Week 104	week 104	Number of patients in remission according to SDAI (Simplified Disease Activity Index) at week 104. SDAI is calculated with the following formula : TJC28+SJC28+GH+GA ph in which TJC is the number of tender joints, SJC the number of Swollen Joint and GH the general health assessed by the patient on a Visual Analogue Scale (VAS) and GA ph the general assessment of the physician on a VAS. A value below 3.3 is indicating remission, between 3.4 and 11.0 low disease activity, between 11.1 and 26.0 moderate disease activity and above 26.0 high disease activity.
Secondary	Clinically Significant Change in HAQ Score	Baseline-week104	Number of patients with a change of \> 0.22 in the Health Assessment Questionnaire (HAQ) score over the period between baseline and week 104. A change of \> 0.22 in this score is considered as clinical relevant for rheumatoid arthritis patients.

Source ClinicalTrials.gov

Outcomes7

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Remission According to DAS28-CRP at Week 16	week 16	ITT = intention to treat analysis (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Remission According to DAS28-CRP at Week 52	week 52	ITT (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.	Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Remission According to DAS28-CRP at Week 104	week 104	ITT (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Remission According to SDAI (Simple Disease Activity Index) at Week 16	week 16	ITT (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Remission According to SDAI at Week 52	week 52	ITT (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Remission According to SDAI at Week 104	week 104	ITT = intention to treat analysis (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Clinically Significant Change in HAQ Score	Baseline-week104	ITT = intention to treat analysis (all randomized subjects included), missing data imputed with Expectation Maximization on complete w104 database.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group35

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

Outcome	Group	Value	Units
Remission According to DAS28-CRP at Week 16	CoBRA Classic High Risk Group	69	Participants
Remission According to DAS28-CRP at Week 16	CoBRA Slim High Risk Group	72	Participants
Remission According to DAS28-CRP at Week 16	CoBRA Avant-garde High Risk Group	61	Participants
Remission According to DAS28-CRP at Week 16	CoBRA Slim Low Risk Group	25	Participants
Remission According to DAS28-CRP at Week 16	Tight Step Up Low Risk Group	23	Participants
Remission According to DAS28-CRP at Week 52	CoBRA Classic High Risk Group	63	Participants
Remission According to DAS28-CRP at Week 52	CoBRA Slim High Risk Group	57	Participants
Remission According to DAS28-CRP at Week 52	CoBRA Avant-garde High Risk Group	57	Participants
Remission According to DAS28-CRP at Week 52	CoBRA Slim Low Risk Group	29	Participants
Remission According to DAS28-CRP at Week 52	Tight Step Up Low Risk Group	29	Participants

1 to 10 of 35Source ClinicalTrials.gov

See all 35 results by group

Participant flow25

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

Period	Milestone	Group	Participants
Overall Study	STARTED	CoBRA Classic High Risk Group	98
Overall Study	STARTED	CoBRA Slim High Risk Group	98
Overall Study	STARTED	CoBRA Avant-garde High Risk Group	93
Overall Study	STARTED	CoBRA Slim Low Risk Group	43
Overall Study	STARTED	Tight Step Up Low Risk Group	47
Overall Study	Week 16	CoBRA Classic High Risk Group	94
Overall Study	Week 16	CoBRA Slim High Risk Group	96
Overall Study	Week 16	CoBRA Avant-garde High Risk Group	91
Overall Study	Week 16	CoBRA Slim Low Risk Group	39
Overall Study	Week 16	Tight Step Up Low Risk Group	47

1 to 10 of 25Source ClinicalTrials.gov

See all 25 participant flow

Adverse events490

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	Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	CoBRA Classic High Risk Group	28	98	50
other	Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	CoBRA Slim High Risk Group	42	98	72
other	Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	CoBRA Avant-garde High Risk Group	29	93	46
other	Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	CoBRA Slim Low Risk Group	14	43	29
other	Upper respiratory tract infection	Respiratory, thoracic and mediastinal disorders	Tight Step Up Low Risk Group	18	47	40
other	Abdominal pain	Gastrointestinal disorders	CoBRA Classic High Risk Group	25	98	27
other	Abdominal pain	Gastrointestinal disorders	CoBRA Slim High Risk Group	23	98	26
other	Abdominal pain	Gastrointestinal disorders	CoBRA Avant-garde High Risk Group	37	93	46
other	Abdominal pain	Gastrointestinal disorders	CoBRA Slim Low Risk Group	11	43	14
other	Abdominal pain	Gastrointestinal disorders	Tight Step Up Low Risk Group	9	47	9

1 to 10 of 490Source ClinicalTrials.gov

See all 490 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CoBRA Classic High Risk Group	1	98
Total, all-cause mortality	CoBRA Slim High Risk Group	1	98
Total, all-cause mortality	CoBRA Avant-garde High Risk Group	0	93
Total, all-cause mortality	CoBRA Slim Low Risk Group	0	43
Total, all-cause mortality	Tight Step Up Low Risk Group	0	47
Total, other adverse events	CoBRA Classic High Risk Group	85	98
Total, other adverse events	CoBRA Slim High Risk Group	88	98
Total, other adverse events	CoBRA Avant-garde High Risk Group	84	93
Total, other adverse events	CoBRA Slim Low Risk Group	34	43
Total, other adverse events	Tight Step Up Low Risk Group	45	47

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers15

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
9251634	BACKGROUND	PubMed
18039681	BACKGROUND	PubMed
18050189	BACKGROUND	PubMed
18618520	BACKGROUND	PubMed
19169906	BACKGROUND	PubMed
25359382	RESULT	PubMed
25889222	RESULT	PubMed
26058860	BACKGROUND	PubMed
27432356	RESULT	PubMed
31236568	DERIVED	PubMed

1 to 10 of 15

See all 15 papers

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.

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