Trial · NCT00551707

Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis

NCT00551707, Phase 2, Completed, Zalicus; results first posted 2014-04-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis. Trials, record NCT00551707. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00551707

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Trial

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

Title: Multicenter Study to Evaluate CRx-102 vs. Each of Its Components to Treat Active Rheumatoid Arthritis
NCT number: NCT00551707
Status: Completed
Phases: Phase 2
Enrollment: 51 participants, actual
Lead sponsor: Zalicus
Conditions: Rheumatoid Arthritis
Interventions: CRx-102 (2.7/180), prednisolone, dipyridamole, placebo, CRx-102 (2.7/360)
First posted: 2007-10-31
Last updated: 2014-04-29
Results first posted: 2014-04-29

Source ClinicalTrials.gov

Registered outcomes4

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

List	Outcome	Time frame	Description
Primary	Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population	Day 98	Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.
Secondary	Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population	baseline to day 98	Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.
Secondary	To Assess the Superiority of CRx-102 Compared to Prednisolone and Dipyridamole Using American College of Rheumatology Rating Scale (20% or More Improvement; ACR20) Calculated From Baseline to Day 98 in Subjects With Active Rheumatoid Arthritis	baseline to day 98	Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.
Secondary	To Assess the Efficacy of CRx-102 Compared to Placebo Using ACR 20 Calculated From Baseline to Day 98	baseline to 98 Days	Preliminary review of the efficacy dataset revealed that the efficacy dataset was not robust enough to support an extensive formal efficacy analysis as described in the SAP. Therefore, only the CRP values over time and the percent change in CRP values in the As-Treated population were calculated.

Source ClinicalTrials.gov

Outcomes4

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

Type	Outcome	Time frame	Population	Units	Measured as
SECONDARY	Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population	baseline to day 98	As treated population	percentage of change from baseline	MEDIAN
SECONDARY	To Assess the Superiority of CRx-102 Compared to Prednisolone and Dipyridamole Using American College of Rheumatology Rating Scale (20% or More Improvement; ACR20) Calculated From Baseline to Day 98 in Subjects With Active Rheumatoid Arthritis	baseline to day 98
PRIMARY	Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population	Day 98	As treated population	mg/L	MEDIAN
SECONDARY	To Assess the Efficacy of CRx-102 Compared to Placebo Using ACR 20 Calculated From Baseline to Day 98	baseline to 98 Days

Source ClinicalTrials.gov

Results by group10

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

Outcome	Group	Value	Spread	Units
Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population	CRx-102 (2.7/180)	-29.90	Full Range 18.45	percentage of change from baseline
Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population	CRx-102 (2.7/360)	-40.84	Full Range 66.80	percentage of change from baseline
Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population	Prednisolone	15.92	Full Range 1453.54	percentage of change from baseline
Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population	Dipyridamole	-33.67	Full Range 30.43	percentage of change from baseline
Percent Change From Baseline to Day 98 in C-reactive Protein (CRP) Values - As Treated Population	Placebo	-27.64	Full Range -35.0 to 203.3	percentage of change from baseline
Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population	CRx-102 (2.7/180)	12.85	Full Range 5.39	mg/L
Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population	CRx-102 (2.7/360)	14.25	Full Range 15.52	mg/L
Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population	Prednisolone	21.85	Full Range 27.10	mg/L
Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population	Dipyridamole	16.60	Full Range 16.22	mg/L
Absolute C-reactive Protein (CRP) Values at Day 98 - As Treated Population	Placebo	2.68	Full Range 4.88	mg/L

Source ClinicalTrials.gov

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	CRx-102 (2.7/180)	4
Overall Study	STARTED	CRx-102 (2.7/360)	22
Overall Study	STARTED	Prednisolone	13
Overall Study	STARTED	Dipyridamole	8
Overall Study	STARTED	Placebo	4
Overall Study	COMPLETED	CRx-102 (2.7/180)	4
Overall Study	COMPLETED	CRx-102 (2.7/360)	16
Overall Study	COMPLETED	Prednisolone	10
Overall Study	COMPLETED	Dipyridamole	4
Overall Study	COMPLETED	Placebo	3

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events25

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
other	Headache	Nervous system disorders	CRx-102 (Dose 1)	0	4
other	Headache	Nervous system disorders	CRx-102 (Dose 2)	6	22
other	Headache	Nervous system disorders	Prednisolone	1	13
other	Headache	Nervous system disorders	Dipyridamole	2	8
other	Headache	Nervous system disorders	Placebo	2	4
other	Nausea	Gastrointestinal disorders	CRx-102 (Dose 1)	0	4
other	Nausea	Gastrointestinal disorders	CRx-102 (Dose 2)	0	22
other	Nausea	Gastrointestinal disorders	Prednisolone	0	13
other	Nausea	Gastrointestinal disorders	Dipyridamole	2	8
other	Nausea	Gastrointestinal disorders	Placebo	1	4

1 to 10 of 25Source ClinicalTrials.gov

See all 25 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	CRx-102 (Dose 1)
Total, all-cause mortality	CRx-102 (Dose 2)
Total, all-cause mortality	Prednisolone
Total, all-cause mortality	Dipyridamole
Total, all-cause mortality	Placebo
Total, other adverse events	CRx-102 (Dose 1)	0	4
Total, other adverse events	CRx-102 (Dose 2)	10	22
Total, other adverse events	Prednisolone	2	13
Total, other adverse events	Dipyridamole	4	8
Total, other adverse events	Placebo	2	4

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

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/NCT00551707

GET https://conductscience.org/api/trials/v1/NCT00551707/events?page=2

API reference For AI assistants