Rheumatoid ArthritisPhase 2NCT00747214
A Study Comparing CRx-102 Plus Disease-modifying Anti-rheumatic Drug (DMARD) Therapy to Placebo Plus DMARD Therapy in RA
A Phase 2 study testing CRx-102 and DMARD Therapy in people with Rheumatoid Arthritis, run by Zalicus.
Trial summary
This study was a Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to that of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects with Rheumatoid Arthritis. 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?
- CRx-102 and DMARD Therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Nov 2006
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Was 18 years of age of older
- Had moderate to severe RA
- Had at least 3 swollen joints (maximum 28) and 3 tender joints (maximum 28)
- Had a Baseline CRP level of at least 2.2 mg/L and a DAS28 score >4.5
- Had been on DMARD therapy for at least 3 months and have been on a stable dose of DMARD therapy for at least 28 days prior to enrollment
- Had a negative pregnancy test (females)
- Was not taking glucocorticoids at screening
Who cannot join
- Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (barriers or abstinence). Female subjects using hormonal birth control are not to be enrolled.
- Subject is currently taking any steroids (glucocorticoids). All glucocorticoids must be discontinued for at least one month prior to entering study. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study.
- Subject is currently taking more than 81 mg of aspirin daily.
- Subject is currently taking a statin, unless she/he has been on a stable dose of the same statin for at least 3 months prior to entering into the trial.
- Subject has any active infections or recent surgical procedures within 30 days of study initiation.
- Subject has uncontrolled diabetes mellitus as defined by a HbA1C value ≥ 7.0%.
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- Subject knowingly has HIV or Hepatitis.
- Subject has undergone administration of any investigational drug within 30 days of study initiation.
- Subject has a history of hypersensitivity to steroids and/or dipyridamole.
- Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
About this study
Official title: A Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to That of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects With RA
This study was a Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to that of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects with Rheumatoid Arthritis. This Phase II, 6-week blinded study was planned for 60 subjects with moderate to severe rheumatoid arthritis (RA).
Read the detailed description
The primary objective of this study was to:
- Compare the response of CRx-102 plus DMARD therapy to placebo plus DMARD therapy in lowering CRP levels in rheumatoid arthritis subjects.
The secondary objectives of this study were to:
- Evaluate the changes in inflammatory cytokines in subjects treated with CRx-102 plus DMARD therapy to placebo plus DMARD therapy.
- Evaluate the efficacy of CRx-102 plus DMARD therapy to placebo plus DMARD therapy using ACR-20 and DAS28 indices as well as fatigue scales.
- Conditions
- Rheumatoid Arthritis
- Being tested
- CRx-102, Placebo, DMARD Therapy
- Keywords
- Rheumatoid Arthritis, RA, DMARD, CRP
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CRx-102Drug
Also called Prednisolone plus dipyridamole
PlaceboDrug
Also called sugar pill
DMARD TherapyDrug
Also called Disease modifying anti-rheumatic drug therapy
DMARD therapy can include methotrexate or other DMARD therapy
| Study group | Role | What they receive |
|---|---|---|
| CRx-102 plus DMARD therapy | Experimental | Not described Receives: Drug: CRx-102; Drug: DMARD Therapy |
| Placebo plus DMARD therapy | Placebo comparator | Not described Receives: Drug: Placebo; Drug: DMARD Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in CRP From Baseline to Day 42
The primary efficacy variable in this study was the change in CRP from Baseline (Day 1/Visit 2) to End of Study (Day 42/Visit 5). Blood samples for the analysis of serum CRP were taken at each visit.
Measured: Baseline and Day 42
Secondary outcomes (3)
Improvement of ACR 20 Scores at End of Study (Day 42/Visit 5)
The percentage of subjects in each group that achieved an ACR 20 response on Day 42
Measured: Day 42
Change in DAS28 Score From Baseline to Day 42
To calculate the DAS28, the number of swollen joints and tender joints should be assessed using 28-joint counts, the ESR should have been measured in mm/hour, and the patient's general health (GH) or global disease activity measured on a Visual Analog Scale (VAS) of 100 mm must be obtained. Using these data, the DAS28 could be calculated using the following formula: DAS28 = 0.56 * sqrt(tender28) + 0.28 * sqrt(swollen28) + 0.70 * ln(ESR) + 0.014 * GH. The DAS28 provides a number between 0 and 10 that indicates the current activity of RA in the subject. A DAS28 above 5.1 means high disease activity and below 3.2 indicates low activity. Remission is achieved when a DAS28 score is lower than 2.6. The DAS28 measurements were to be taken at each visit.
Measured: Baseline and Day 42
Change in Fatigue (MAF Scale) Score From Baseline to Day 42
The Multidimensional Assessment of Fatigue (MAF) scale is a self-administered, 16 item questionnaire to measure self-reported fatigue (http://www.son.washington.edu/research/maf/). The following steps were used to calculate a single score ranging from 1 (no fatigue) to 50 (severe fatigue).
- Convert item #15 to a 0 to 10 scale by multiplying each score by 2.5
- Sum items #1, 2, and 3
- Average items #4 through 14
- Add results from above Steps 1 through 3 to obtain a single score
A score was not be assigned to items #4 through 14 if a respondent indicated they "did not engage any activity for reasons other than fatigue." If respondent selected "no fatigue" on item #1, a 0 was to be assigned to items #2 through 16; item #16 was not included in the global fatigue index.
Measured: Baseline and Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2008 (estimated)
- Study startNov 2004
- Primary completionSep 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zalicus
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Margaret Lee, PhD, Study director, Zalicus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00747214
- Sponsor's protocol ID
- CRx-102-002
- Status last verified
- Apr 2014
- First submitted
- 3 Sep 2008
- Last updated
- 20 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to That of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects With RA
- ClinicalTrials.gov ID
- NCT00747214
- Acronym / sponsor ID
- CRx-102-002
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, RA, DMARD, CRP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- ZalicusIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Sep 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 5 Sep 2008 (estimated)
- Results
- Posted 20 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was a Multicenter, Randomized, Blinded Study Comparing the Effect of CRx-102 Plus DMARD Therapy to that of Placebo Plus DMARD Therapy on Serum C Reactive Protein (CRP) and Cytokines in Subjects with Rheumatoid Arthritis. This Phase II, 6-week blinded study was planned for 60 subjects with moderate to severe rheumatoid arthritis (RA).
Detailed description
The primary objective of this study was to:
- Compare the response of CRx-102 plus DMARD therapy to placebo plus DMARD therapy in lowering CRP levels in rheumatoid arthritis subjects.
The secondary objectives of this study were to:
- Evaluate the changes in inflammatory cytokines in subjects treated with CRx-102 plus DMARD therapy to placebo plus DMARD therapy.
- Evaluate the efficacy of CRx-102 plus DMARD therapy to placebo plus DMARD therapy using ACR-20 and DAS28 indices as well as fatigue scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRx-102 plus DMARD therapy | Experimental | Drug: CRx-102, Drug: DMARD Therapy |
| Placebo plus DMARD therapy | Placebo comparator | Drug: Placebo, Drug: DMARD Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Was 18 years of age of older
- Had moderate to severe RA
- Had at least 3 swollen joints (maximum 28) and 3 tender joints (maximum 28)
- Had a Baseline CRP level of at least 2.2 mg/L and a DAS28 score >4.5
- Had been on DMARD therapy for at least 3 months and have been on a stable dose of DMARD therapy for at least 28 days prior to enrollment
Key exclusion criteria (10 listed)
- Female subject is pregnant or lactating or of child bearing potential not using acceptable methods of birth control (barriers or abstinence). Female subjects using hormonal birth control are not to be enrolled.
- Subject is currently taking any steroids (glucocorticoids). All glucocorticoids must be discontinued for at least one month prior to entering study. Intraarticular, intramuscular, or intravenous glucocorticoids must not have been given at least 6 weeks prior to entering the study.
- Subject is currently taking more than 81 mg of aspirin daily.
- Subject is currently taking a statin, unless she/he has been on a stable dose of the same statin for at least 3 months prior to entering into the trial.
- Subject has any active infections or recent surgical procedures within 30 days of study initiation.
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 |
|---|---|---|
| CRx-102Also: Prednisolone plus dipyridamole | Drug | CRx-102 plus DMARD therapy |
| PlaceboAlso: sugar pill | Drug | Placebo plus DMARD therapy |
| DMARD TherapyAlso: Disease modifying anti-rheumatic drug therapyDMARD therapy can include methotrexate or other DMARD therapy | Drug | CRx-102 plus DMARD therapy, Placebo plus DMARD therapy |
Primary outcome
Change in CRP From Baseline to Day 42
Time frame: Baseline and Day 42
The primary efficacy variable in this study was the change in CRP from Baseline (Day 1/Visit 2) to End of Study (Day 42/Visit 5). Blood samples for the analysis of serum CRP were taken at each visit.
3 secondary outcomes
Improvement of ACR 20 Scores at End of Study (Day 42/Visit 5)
Time frame: Day 42
Change in DAS28 Score From Baseline to Day 42
Time frame: Baseline and Day 42
Change in Fatigue (MAF Scale) Score From Baseline to Day 42
Time frame: Baseline and Day 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Margaret Lee, PhD study director
Zalicus
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CRx-102 and DMARD Therapy in people with Rheumatoid Arthritis, run by Zalicus.
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 7 inclusion and 10 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: finished, as of the sponsor's last update on 20 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 20 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in CRP From Baseline to Day 42 (time frame: Baseline and Day 42). 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 20 May 2014; AzTrials last refreshed its copy on 29 Oct 2026.