Rheumatoid ArthritisPhase 2NCT01612377
Long Term Safety Trial of z102 and Prednisone in Patients With Moderate to Severe Rheumatoid Arthritis
A Phase 2 study testing Prednisolone-Dipyridamole and Prednisone in people with Rheumatoid Arthritis, run by Zalicus at 1 site in Serbia.
Trial summary
This study will compare an experimental drug called Z102 (combination of prednisolone and dipyridamole, against prednisone 5mg and prednisone 7.5mg in patients with moderate to severe Rheumatoid Arthritis for a period of 52 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Prednisolone-Dipyridamole and Prednisone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSerbia
- Study dates
- Mar 2012to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have completed all 12 weeks of Protocol Z102-008 or discontinued after participating in at least 6 weeks of the randomized withdrawal portion of Z102-008 for acceptable reasons
- Have met all inclusion/exclusion criteria for enrollment into Protocol Z102-008
- Have been on DMARD therapy for at least 90 days and have been on a stable DMARD dose without dosage adjustment or modification for 6 weeks prior to enrollment into Protocol Z102-008, and be able to maintain the same dose of conventional DMARD therapy during Protocol Z102-009 participation
Who cannot join
- Did not complete 6 weeks of the double-blind section of Protocol Z102-008, or was discontinued from Protocol Z102-008 for reasons of an AE, protocol violation, or non-compliance
- Active cardiovascular disease, unless well controlled by appropriate treatment, for a minimum of 3 months prior to screening for enrollment into Protocol Z102-008
- Currently taking aspirin for reasons other than for cardiovascular prophylaxis or their total daily dose is greater than 325 mg
- Taking oral steroids at a daily prednisone dose, or the equivalent, of >10 mg/day within the past 2 weeks
- Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering study Protocol Z102-008 or Protocol Z102-009, at any time during the study, or be anticipated to be given at any time during the study
- The need to continue the use of one or multiple NSAIDs at the same time, or use acetaminophen on a chronic basis
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- All opiate use is prohibited.
- Use of any other medications or herbs or non-pharmacological treatments (e.g., acupuncture) used for the treatment of pain is prohibited
- Has, or has had, any active severe infections or recent invasive surgical procedures within 30 days of Protocol Z102-008 or Protocol Z102-009 initiation
- HIV, hepatitis B, or hepatitis C infection
- Has undergone administration of any investigational drug within 30 days of study
- All biologic agents are excluded for 90 days prior to Screening and during the conduct of Protocol Z102-008, and Protocol Z102-009
- Has undergone administration of rituximab or any B-cell depleting investigational drugs within 6 months of Protocol Z102-008 Screening or Protocol Z102-009 initiation, or at any time during participation in study Protocol Z102-008
- Has a history of hypersensitivity reaction to glucocorticoids and/or dipyridamole
- Known or suspected history of alcohol or drug abuse within 2 years prior to Screening for Protocol Z102-008
- Has any other medical condition which may interfere with the conduct of this study in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II, Double-blind, Controlled, Multi-center, Randomized, Long Term Safety Trial of z102 and Prednisone (5 mg or 7.5 mg) in Patients With Moderate to Severe Rheumatoid Arthritis
This study will compare an experimental drug called Z102 (combination of prednisolone and dipyridamole, against prednisone 5mg and prednisone 7.5mg in patients with moderate to severe Rheumatoid Arthritis for a period of 52 weeks.
Read the detailed description
This is a long-term Phase II safety study of approximately 52 weeks in duration. Eligible patients will have completed at least 6 weeks of Protocol Z102-008 and will have met all inclusion and exclusion criteria for this study.
All patients will be up-titrated on Z102 over 3 weeks or will receive prednisone 5.0 mg or 7.5 mg:
Primary objectives:
- Adverse events (AEs)
- Vital signs
- Clinical laboratory and clinical chemistry evaluations
Secondary objectives:
- Joint imaging and bone density
- DAS28-CRP and individual components
- Patient Global Assessment of Disease Activity
- American College of Rheumatology criteria (ACR 20, ACR 50, ACR 70)
- Multidimensional Assessment of Fatigue (MAF)
- Time to failure
- Conditions
- Rheumatoid Arthritis
- Being tested
- Prednisolone-Dipyridamole, Prednisone
- Keywords
- Moderate to Severe
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisolone-DipyridamoleDrug
Also called Z102
Oral, QD
PrednisoneDrug
Oral QD Prednisone 5mg
prednisoneDrug
Oral, QD prednisone 7.5mg
| Study group | Role | What they receive |
|---|---|---|
| prednisolone-dipyridamole | Experimental | Not described Receives: Drug: Prednisolone-Dipyridamole |
| prednisone 5mg | Active comparator | Not described Receives: Drug: Prednisone |
| prednisone 7.5mg | Active comparator | Not described Receives: Drug: prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in incidence rates of adverse events between treament groups
Measured: 12 months
Secondary outcomes (1)
Joint imaging
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2012 (estimated)
- Study startMar 2012
- Primary completionJul 2013 (estimated)
- Study completionSep 2013 (estimated)
Why it stopped: missed endpoint of meaningful clinical benefit, compared to prednisolone 2.7mg
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zalicus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gene Wright, PHARM.D, PH.D, Study director, Zalicus, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01612377
- Sponsor's protocol ID
- Z102-009
- Status last verified
- Sep 2012
- First submitted
- 22 Feb 2012
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Double-blind, Controlled, Multi-center, Randomized, Long Term Safety Trial of z102 and Prednisone (5 mg or 7.5 mg) in Patients With Moderate to Severe Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01612377
- Acronym / sponsor ID
- Z102-009
- Conditions
- Rheumatoid Arthritis
- Keywords
- Moderate to Severe
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: missed endpoint of meaningful clinical benefit, compared to prednisolone 2.7mg
- Enrolment
- 18 participants (actual)
- Lead sponsor
- ZalicusIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 5 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will compare an experimental drug called Z102 (combination of prednisolone and dipyridamole, against prednisone 5mg and prednisone 7.5mg in patients with moderate to severe Rheumatoid Arthritis for a period of 52 weeks.
Detailed description
This is a long-term Phase II safety study of approximately 52 weeks in duration. Eligible patients will have completed at least 6 weeks of Protocol Z102-008 and will have met all inclusion and exclusion criteria for this study.
All patients will be up-titrated on Z102 over 3 weeks or will receive prednisone 5.0 mg or 7.5 mg:
Primary objectives:
- Adverse events (AEs)
- Vital signs
- Clinical laboratory and clinical chemistry evaluations
Secondary objectives:
- Joint imaging and bone density
- DAS28-CRP and individual components
- Patient Global Assessment of Disease Activity
- American College of Rheumatology criteria (ACR 20, ACR 50, ACR 70)
- Multidimensional Assessment of Fatigue (MAF)
- Time to failure
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| prednisolone-dipyridamole | Experimental | Drug: Prednisolone-Dipyridamole |
| prednisone 5mg | Active comparator | Drug: Prednisone |
| prednisone 7.5mg | Active comparator | Drug: prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Have completed all 12 weeks of Protocol Z102-008 or discontinued after participating in at least 6 weeks of the randomized withdrawal portion of Z102-008 for acceptable reasons
- Have met all inclusion/exclusion criteria for enrollment into Protocol Z102-008
- Have been on DMARD therapy for at least 90 days and have been on a stable DMARD dose without dosage adjustment or modification for 6 weeks prior to enrollment into Protocol Z102-008, and be able to maintain the same dose of conventional DMARD therapy during Protocol Z102-009 participation
Key exclusion criteria (16 listed)
- Did not complete 6 weeks of the double-blind section of Protocol Z102-008, or was discontinued from Protocol Z102-008 for reasons of an AE, protocol violation, or non-compliance
- Active cardiovascular disease, unless well controlled by appropriate treatment, for a minimum of 3 months prior to screening for enrollment into Protocol Z102-008
- Currently taking aspirin for reasons other than for cardiovascular prophylaxis or their total daily dose is greater than 325 mg
- Taking oral steroids at a daily prednisone dose, or the equivalent, of >10 mg/day within the past 2 weeks
- Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering study Protocol Z102-008 or Protocol Z102-009, at any time during the study, or be anticipated to be given at any time during the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisolone-DipyridamoleAlso: Z102Oral, QD | Drug | prednisolone-dipyridamole |
| PrednisoneOral QD Prednisone 5mg | Drug | prednisone 5mg |
| prednisoneOral, QD prednisone 7.5mg | Drug | prednisone 7.5mg |
Primary outcome
Difference in incidence rates of adverse events between treament groups
Time frame: 12 months
1 secondary outcome
Joint imaging
Time frame: 12 months
Results and safety
The study was stopped early (reason given: missed endpoint of meaningful clinical benefit, compared to prednisolone 2.7mg). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gene Wright, PHARM.D, PH.D study director
Zalicus, Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Prednisolone-Dipyridamole and Prednisone in people with Rheumatoid Arthritis, run by Zalicus at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: missed endpoint of meaningful clinical benefit, compared to prednisolone 2.7mg). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in incidence rates of adverse events between treament groups (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2012.