Trial · NCT01369745

A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis

NCT01369745, Phase 2, Completed, Zalicus; results first posted 2014-04-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis. Trials, record NCT01369745. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01369745

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Trial

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

Title: A Phase II Trial Comparing Z-102 With Placebo In Patients With Moderate To Severe Rheumatoid Arthritis
NCT number: NCT01369745
Status: Completed
Phases: Phase 2
Enrollment: 294 participants, actual
Lead sponsor: Zalicus
Conditions: Rheumatoid Arthritis
Interventions: Prednisolone, dipyridamole, Prednisone, Z102, placebo
First posted: 2011-06-09
Last updated: 2014-05-15
Results first posted: 2014-04-30
Limitations and caveats: The study did not progress past the first stage of adaptive randomization. The number of subjects allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg arms was insufficient to allow analysis of the secondary objectives.

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in DAS28-CRP at 12 Weeks	baseline to week 12	The primary efficacy endpoint was the mean change in Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12. The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of \<3.2 suggests a low level of disease activity, while a score of \>5.1 suggests a high level of disease activity. Using the DAS-CRP as a continuous scale allows investigators (and clinicians) to measure a clinically meaningful endpoint following institution of a therapeutic intervention. In RA, clinical remission would therefore be graded as a DAS28 score of ≤3.2 with disease flare accompanying scores of ≥5.1; well-controlled disease is best characterized as fitting in between these two scores.
Secondary	Change From Baseline in DAS28-CRP Individual Components at 12 Weeks	Baseline to week 12	The mean change in the individual components of the Disease Activity Score 28 using C-reactive protein (DAS28-CRP) from baseline to Week 12 which included individual assessment of Tender Joint Count (28-joint assessment), Swollen Joint Count (28-joint assessment), Patient Global Assessment of Disease Activity and absolute CRP level. In each case, higher scores indicate more disease activity. The DAS28-CRP is a composite measure of inflammation in Rheumatoid Arthritis and incorporates a tender and swollen joint count, CRP and Patient Global Assessment of Disease Activity expressed in a Gaussian distribution of variables ranging from 0 to 10. A DAS28-CRP score of \<3.2 suggests a low level of disease activity, while a score of \>5.1 suggests a high level of disease activity.
Secondary	Percentage of Subjects Achieving ACR20, ACR50 and ACR70 at 12 Weeks	Week 12	The American College of Rheumatology (ACR) 20 is a widely accepted composite index of improvement in RA proposed by the ACR (Fransen and van Riel 2009). ACR20 refers to a composite improvement of 20% in swollen joint count, tender joint count, and 3 or more of the following 5 measures:Physician's Global Assessment of Disease Activity, Patient's Global Assessment of Disease Activity, Patient Pain VAS, Patient's self-addressed disability (HAQ) (Arnet 1988 and Felson 1995), Acute-phase reactant (ESR or CRP) The ACR 50 and ACR 70 are similar tools, used to indicate 50% and 70% improvement, respectively.
Secondary	Multidimensional Assessment of Fatigue (MAF) at Week 12	week 12	The Multidimensional Assessment of Fatigue (MAF) scale contains 16 items and measures four dimensions of fatigue: severity (#1-2), distress (#3), degree of interference in activities of daily living (#4-14), and timing (#15-16). Fourteen items contain numerical rating scales (#1-14) and two items have multiple-choice responses (#15-16). Respondents are asked to reflect on fatigue patterns for the past week. To calculate the Global Fatigue Index (GFI): Convert item #15 to a 0-10 scale by multiplying each score by 2.5 and then sum items #1, 2, 3, average #4-14, and newly scored item #15. Scores range from 1 (no fatigue) to 50 (severe fatigue). Do not assign a score to items #4-14 if respondent indicated they "do not do any activity for reasons other than fatigue." If respondents select no fatigue on item #1, assign a zero to items #2-16. Item #16 is not included in the Global Fatigue Index.
Secondary	Time to Failure (Days)	Baseline to 12 weeks	Patients will be monitored for addition of any DMARD or withdrawal due to flare. The time to failure is defined as the duration of study participation (in days) until a qualifying event or completion of study treatment, whichever comes first.

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in DAS28-CRP at 12 Weeks	baseline to week 12	The efficacy analysis population includes all 252 subjects who received at least one dose of study drug after randomization and who provided at least one post-baseline measurement of the primary endpoint	units on a scale	MEAN
SECONDARY	Change From Baseline in DAS28-CRP Individual Components at 12 Weeks	Baseline to week 12	Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.
SECONDARY	Percentage of Subjects Achieving ACR20, ACR50 and ACR70 at 12 Weeks	Week 12	Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.
SECONDARY	Multidimensional Assessment of Fatigue (MAF) at Week 12	week 12	Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.
SECONDARY	Time to Failure (Days)	Baseline to 12 weeks	Because the study never progressed past the first stage of the adaptive randomization, the number of subjects who were allocated to the dipyridamole 360 mg, prednisolone 2.7 mg, and prednisone 5 mg treatment arms was insufficient (underpowered) to allow analysis of the secondary objectives.

Source ClinicalTrials.gov

Results by group5

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

Outcome	Group	Value	Spread	Units
Change From Baseline in DAS28-CRP at 12 Weeks	Prednisolone	-1.147	Standard Deviation 0.235	units on a scale
Change From Baseline in DAS28-CRP at 12 Weeks	Dipyridamole	-0.813	Standard Deviation 0.216	units on a scale
Change From Baseline in DAS28-CRP at 12 Weeks	Prednisone	-1.237	Standard Deviation 0.296	units on a scale
Change From Baseline in DAS28-CRP at 12 Weeks	Z102	-0.907	Standard Deviation 0.149	units on a scale
Change From Baseline in DAS28-CRP at 12 Weeks	Placebo	-0.538	Standard Deviation 0.153	units on a scale

Source ClinicalTrials.gov

Participant flow15

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Prednisolone	32
Overall Study	STARTED	Dipyridamole	41
Overall Study	STARTED	Prednisone	18
Overall Study	STARTED	Z102	84
Overall Study	STARTED	Placebo	83
Overall Study	COMPLETED	Prednisolone	25
Overall Study	COMPLETED	Dipyridamole	28
Overall Study	COMPLETED	Prednisone	16
Overall Study	COMPLETED	Z102	64
Overall Study	COMPLETED	Placebo	65

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events135

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	Prednisolone	1	32
other	Headache	Nervous system disorders	Dipyridamole	11	41
other	Headache	Nervous system disorders	Prednisone	0	18
other	Headache	Nervous system disorders	Z102	13	84
other	Headache	Nervous system disorders	Placebo	4	83
other	Sciatica	Nervous system disorders	Prednisolone	0	32
other	Sciatica	Nervous system disorders	Dipyridamole	0	41
other	Sciatica	Nervous system disorders	Prednisone	0	18
other	Sciatica	Nervous system disorders	Z102	2	84
other	Sciatica	Nervous system disorders	Placebo	1	83

1 to 10 of 135Source ClinicalTrials.gov

See all 135 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Prednisolone
Total, all-cause mortality	Dipyridamole
Total, all-cause mortality	Prednisone
Total, all-cause mortality	Z102
Total, all-cause mortality	Placebo
Total, other adverse events	Prednisolone	6	32
Total, other adverse events	Dipyridamole	30	41
Total, other adverse events	Prednisone	5	18
Total, other adverse events	Z102	38	84
Total, other adverse events	Placebo	33	83

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/NCT01369745

GET https://conductscience.org/api/trials/v1/NCT01369745/events?page=2

API reference For AI assistants