Erosive Osteoarthritis of the HandPhase 2NCT01200472
Efficacy Study of Apremilast (CC-10004) in Subjects With Erosive Hand Osteoarthritis
A Phase 2 study testing Apremilast in people with Erosive Osteoarthritis of the Hand, run by University of Erlangen-Nürnberg Medical School at 3 sites in Germany.
Trial summary
STUDY DESIGN: This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study in 30 patients with erosive osteoarthritis of interphalangeal joints. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Erosive Osteoarthritis of the Hand
- What is being tested?
- Apremilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 3 sitesGermany
- Study dates
- Aug 2010to Oct 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
- Must have at least two bone erosions detectable in conventional radiographs of the hands at the first carpo-metacarpal joint (CMC), proximal and/or distal interphalangeal joints
- Must have active disease at screening and randomization with at least two swollen and tender PIP and/or DIP joints; with the same two joints affected at both screening and randomization.
- Must have a patients self assessment of pain at baseline of at least 40% on a VAS
- Must have negative rheumatoid factor (RF) and anti-CCP antibody
- Must be able to adhere to the study visit schedule and other protocol requirements
- Male subjects (including those who have had a vasectomy) must agree to use barrier contraception (latex condoms) when engaging in reproductive sexual activity with Females of Childbearing Potential (FCBP)while on study medication and for at least 28 days after taking the last dose of study medication
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- Females of childbearing potential (FCBP) must have a negative urine pregnancy test at Screening and Baseline and must be willing to use one highly-effective form of birth control when engaging in reproductive sexual activity while on study medication and for at least 28 days after taking the last dose of study medication (§ A female of childbearing potential is a sexually mature female who 1) has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been postmenopausal for at least 24 consecutive months (ie, has had menses at any time during the preceding 24 consecutive months).
- Must meet the following laboratory criteria:
- Hemoglobin ≥ 9 g/dL
- Hematocrit ≥ 27%
- White blood cell (WBC) count ≥ 3000 /μL (≥ 3.0 X 109/L) and ≤ 14,000/μL (< 14 X 109/L)
- Platelets ≥ 100,000 /μL (≥ 100 X 109/L)
- Serum creatinine ≤ 1.5 mg/dL (≤ 132.6 μmol/L)
- Total bilirubin ≤ 2.0 mg/dL
- Aspartate transaminase (AST, SGOT]) and alanine transaminase(ALT, SGPT]) ≤ 1.5x upper limit of normal (ULN)
Who cannot join
- History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases
- History of any clinically significant inflammatory disease other than EHOA, especially, but not limited to, rheumatoid arthritis or spondylarthropathies
- History or Diagnosis of Fibromyalgia
- Evidence of gout, pseudogout or hemochromatosis
- Any injury, medical or surgical procedure to the affected joint(s) that may interfere with evaluation of the target hand OA joint(s)
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret data from the study
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- Pregnant or lactating female
- History of active Mycobacterium tuberculosis infection within 3 years prior to the screening visit. Infections that occurred > 3 years prior to entry must have been effectively treated
- History of incompletely treated latent Mycobacterium tuberculosis infection (as indicated by a positive Purified Protein Derivative [PPD] skin test or in vitro test (QuantiFERON Gold®).
- History of infected joint or joint prosthesis within the past 5 years
- Any anti-inflammatory or immunosuppressive therapy for any condition including, but not limited to, glucocorticoids, methotrexate, sulfasalazine, leflunomide, chloroquine, hydroxychloroquine, gold compounds, parenteral corticosteroids, penicillamine, cyclosporine, oral retinoids, mycophenolate mofetil, thioguanine, hydroxyurea, sirolimus, tacrolimus and azathioprine within 35 days of randomization and throughout the study
- Use of NSAIDs within 35 days of randomization and throughout the study
- Intra-articular corticosteroids for the targeted joints within three months prior to randomization
- Intra-articular injection of hyaluronate for the targeted joints within six month prior to randomization
- Use of any investigational medication within 35 days prior to randomization or 5 half-lives if known (whichever is longer)
- Use of "nutraceuticals" and alternative medicine products, unless taken at a stable dose for a minimum of three month prior to randomization
- Any clinically significant abnormality on 12-lead ECG at screening as determined by the investigator
- History of malignancy within previous 5 years (except for treated basal-cell skin carcinoma and/or squamous-cell skin carcinoma)
- High-risk factor(s) for, or a history of, human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus infection
- Have a known history of serious infections (eg, hepatitis, pneumonia, or pyelonephritis) in the previous 3 months Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results
- Have participated in this study before
- Patients who are underage or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent (according to § 40 Abs. 4 and § 41 Abs. 2 und Abs. 3 AMG).
- Patients who possibly are dependent on the sponsor or investigator
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
Prof. Ulf Müller-Ladner, Kerckhoff-Klinik
Bad Nauheim, 61231
Prof. Matthias Schneider, Universitätsklinikum Düsseldorf, Klinik für Endokrinologie, Diabetologie und Rheumatologie
Düsseldorf, 40225
Prof. G. Schett, University Hospital Erlangen
Erlangen, Bavaria, 91054
About this study
Official title: A Phase 2, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel-group,Efficacy Study of Apremilast (CC-10004)in Subjects With Erosive Hand Osteoarthritis
STUDY DESIGN:
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study in 30 patients with erosive osteoarthritis of interphalangeal joints. The study is composed of 4 phases: a pre-randomization phase for up to 35 days followed by a 91-day randomized, double-blind two arm treatment phase, followed by a 77-day open label treatment phase for all study participants and a 28-day observational follow-up phase. Efficacy of the double blind and open label phase will be assessed at study day 84 and 168 after treatment start respectively.
Read more
STUDY DURATION:
The study length will be approximately 231 days for individual patients. With approximately a 12 month recruitment period the study is planned to last from January 2010 until July 2011 (19 months).
STUDY OBJECTIVES:
The primary objective is to evaluate the 84-day efficacy of apremilast 20 mg twice per day [BID], subsequent to a 7-day dose titration, compared with placebo, for the treatment of the symptoms of erosive hand osteoarthritis. Further objectives are to evaluate the effects on pain, disease activity, structural damage, quality of life, safety and tolerability.
- Conditions
- Erosive Osteoarthritis of the Hand
- Being tested
- Apremilast, Placebo
- Keywords
- EHOA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ApremilastDrug
Apremilast is supplied as 10 mg capsules for oral administration. After a 7-day titration phase patients will receive 20 mg PO BID apremilast.
PlaceboDrug
Placebo capsules identical to apremilast
| Study group | Role | What they receive |
|---|---|---|
| Apremilast capsules | Experimental | Apremilast in 10 mg capsules Receives: Drug: Apremilast |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects in each treatment group who achieve a significant 50% improvement in AUSCAN Index at day 84 after treatment start compared with baseline
Proportion of subjects in each treatment group who achieve a significant 50% improvement in AUSCAN Index at day 84 after treatment start compared with baseline.
Measured: Day 84 after treatment start compared with baseline
Secondary outcomes (8)
Absolute values and change from baseline of the Patient self Assessment score (VAS) from baseline, day 84 and day 168 as well as proportion of patients in each treatment group who achieve improvements
Patients self assessment of pain (VAS)
Measured: Day 84 and at day 168 after treatment start compared with Baseline
Change of the Physicians and Patients self assessment of global status (VAS)score from baseline, day 84 and day 168.
Physicians and Patients self assessment of global status (VAS)
Measured: Day 84 and at day 168 after treatment start compared with Baseline
Change of the HAQ score from baseline, day 84 and day 168 in each treatment group who achieve improvements
HAQ
Measured: Day 84 and at day 168 after treatment start compared with Baseline
Change of the SACRAH score from baseline, day 84 and day 168 in each treatment group who achieve improvements
SACRAH
Measured: Day 84 and at day 168 after treatment start compared with Baseline
Change of the duration of the joint stiffness from baseline, day 84 and day 168 in each treatment group who achieve improvements
Duration of joint stiffness
Measured: Day 84 and at day 168 after treatment start compared with Baseline
Change of swollen and tender joints from baseline compared to day 84 and day 168 in each treatment group.
Swollen and tender joint counts
Measured: Day 84 and at day 168 after treatment start compared with Baseline
Measuring radiology changes from baseline, day 84 and day 168 using the RAMRIS score in each treatment.
RAMRIS scoring system
Measured: Day 84 and at day 168 after treatment start compared with Baseline
Changes of the SF36 from baseline, day 84 and day 168 in each treatment group.
SF36
Measured: Day 84 and at day 168 after treatment start compared with Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionAug 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erosive Osteoarthritis of the HandStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Celgene Corporation
- Responsible party
- Sponsor
- Investigators
- Georg Schett, MD, Study director, University Hospital Erlangen, Department of Internal Medicine 3, Rheumatology and Clinical Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01200472
- Sponsor's protocol ID
- ACCOST Version 22-Oct-09
- Other IDs
- 2008-005365-61, 2008
- Status last verified
- Oct 2013
- First submitted
- 8 Apr 2010
- Last updated
- 21 Oct 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Multicenter, Randomized, Doubleblind, Placebo-controlled, Parallel-group,Efficacy Study of Apremilast (CC-10004)in Subjects With Erosive Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT01200472
- Acronym / sponsor ID
- ACCOST Version 22-Oct-09
- Conditions
- Erosive Osteoarthritis of the Hand
- Keywords
- EHOA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Collaborators
- Celgene Corporation
- Study start
- Aug 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Sep 2010 (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.
STUDY DESIGN:
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, efficacy and safety study in 30 patients with erosive osteoarthritis of interphalangeal joints. The study is composed of 4 phases: a pre-randomization phase for up to 35 days followed by a 91-day randomized, double-blind two arm treatment phase, followed by a 77-day open label treatment phase for all study participants and a 28-day observational follow-up phase. Efficacy of the double blind and open label phase will be assessed at study day 84 and 168 after treatment start respectively.
STUDY DURATION:
The study length will be approximately 231 days for individual patients. With approximately a 12 month recruitment period the study is planned to last from January 2010 until July 2011 (19 months).
STUDY OBJECTIVES:
The primary objective is to evaluate the 84-day efficacy of apremilast 20 mg twice per day [BID], subsequent to a 7-day dose titration, compared with placebo, for the treatment of the symptoms of erosive hand osteoarthritis. Further objectives are to evaluate the effects on pain, disease activity, structural damage, quality of life, safety and tolerability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Apremilast capsules | Experimental | Drug: ApremilastApremilast in 10 mg capsules |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Must have at least two bone erosions detectable in conventional radiographs of the hands at the first carpo-metacarpal joint (CMC), proximal and/or distal interphalangeal joints
- Must have active disease at screening and randomization with at least two swollen and tender PIP and/or DIP joints; with the same two joints affected at both screening and randomization.
- Must have a patients self assessment of pain at baseline of at least 40% on a VAS
- Must have negative rheumatoid factor (RF) and anti-CCP antibody
- Must be able to adhere to the study visit schedule and other protocol requirements
Key exclusion criteria (23 listed)
- History of any clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic, or other major diseases
- History of any clinically significant inflammatory disease other than EHOA, especially, but not limited to, rheumatoid arthritis or spondylarthropathies
- History or Diagnosis of Fibromyalgia
- Evidence of gout, pseudogout or hemochromatosis
- Any injury, medical or surgical procedure to the affected joint(s) that may interfere with evaluation of the target hand OA joint(s)
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 |
|---|---|---|
| ApremilastApremilast is supplied as 10 mg capsules for oral administration. After a 7-day titration phase patients will receive 20 mg PO BID apremilast. | Drug | Apremilast capsules |
| PlaceboPlacebo capsules identical to apremilast | Drug | Placebo |
Primary outcome
Proportion of subjects in each treatment group who achieve a significant 50% improvement in AUSCAN Index at day 84 after treatment start compared with baseline
Time frame: Day 84 after treatment start compared with baseline
Proportion of subjects in each treatment group who achieve a significant 50% improvement in AUSCAN Index at day 84 after treatment start compared with baseline.
8 secondary outcomes
Absolute values and change from baseline of the Patient self Assessment score (VAS) from baseline, day 84 and day 168 as well as proportion of patients in each treatment group who achieve improvements
Time frame: Day 84 and at day 168 after treatment start compared with Baseline
Change of the Physicians and Patients self assessment of global status (VAS)score from baseline, day 84 and day 168.
Time frame: Day 84 and at day 168 after treatment start compared with Baseline
Change of the HAQ score from baseline, day 84 and day 168 in each treatment group who achieve improvements
Time frame: Day 84 and at day 168 after treatment start compared with Baseline
Change of the SACRAH score from baseline, day 84 and day 168 in each treatment group who achieve improvements
Time frame: Day 84 and at day 168 after treatment start compared with Baseline
Change of the duration of the joint stiffness from baseline, day 84 and day 168 in each treatment group who achieve improvements
Time frame: Day 84 and at day 168 after treatment start compared with Baseline
Change of swollen and tender joints from baseline compared to day 84 and day 168 in each treatment group.
Time frame: Day 84 and at day 168 after treatment start compared with Baseline
Measuring radiology changes from baseline, day 84 and day 168 using the RAMRIS score in each treatment.
Time frame: Day 84 and at day 168 after treatment start compared with Baseline
Changes of the SF36 from baseline, day 84 and day 168 in each treatment group.
Time frame: Day 84 and at day 168 after treatment start compared with Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2013.
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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.
Georg Schett, MD study director
University Hospital Erlangen, Department of Internal Medicine 3, Rheumatology and Clinical Immunology
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Apremilast in people with Erosive Osteoarthritis of the Hand, run by University of Erlangen-Nürnberg Medical School at 3 sites in Germany.
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 15 inclusion and 23 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 21 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of subjects in each treatment group who achieve a significant 50% improvement in AUSCAN Index at day 84 after treatment start compared with baseline (time frame: Day 84 after treatment start compared with baseline). 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 21 Oct 2013.