Spondylitis Trial of Apremilast for Better Rheumatic Therapy

NCT00944658 | Completed Phase 2 Results

• 2 other identifiers: 1120082008-004229-40
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the effectiveness of apremilast in AS as measured by improvement in patients' signs and symptoms of the disease and changes in imaging. Additionally the safety and tolerability of apremilast in AS will be assessed.

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing spondylitis; Imaging

Outcome Measures

Primary Outcomes (3)

• Changes of Apremilast in Patients With AS, Changes in BASDAI Score From Baseline

  Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), 0 - 10 score, higher reduction in the scores suggest better suboptimal control of disease.

  Baseline and 12 weeks

• Changes of Apremilast on the Signs and Symptoms of AS, Night Pain From Baseline

  This endpoint the night time pain score change was recorded by questionnaire to evaluate the Apremilast effect on symptom, higher reduction better improvement. scale is 0-10

  Baseline and 12 weeks

• Effect of Apremilast in Patients With AS, Changes in BASFI Score

  Bath Ankylosing Spondylitis Functional Index (BASFI), 0 - 10 score, higher reduction in the scores suggest better suboptimal control of disease.

  Baseline and 12 weeks

Secondary Outcomes (1)

• The Safety and Tolerability of Apremilast in AS, Number of Participants With Adverse Events

  16 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

placebo twice a day for 12 weeks, 4 weeks follow up

Drug: Placebo (sugar pill)

Apremilast

ACTIVE COMPARATOR

30 mg twice a day for 12 weeks, 4 weeks follow up

Drug: Apremilast

Interventions

Apremilast DRUG

10mg twice a day, dose was titrated by 20mg every 2 days until the maximum dose 30mg twice a day for 12weeks

Apremilast

Placebo (sugar pill) DRUG

twice a day

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent to participate in this trial
• Diagnosis of ankylosing spondylitis as defined by the modified New York criteria (1984) as follows:
• a history of inflammatory back pain;
• limitation of motion of the lumbar spine in both the sagittal and frontal planes;
• limited chest expansion, relative to standard values for age and sex;
• definite radiographic / imaging evidence of sacroiliitis and/or spinal inflammation
• Patients must have daily spinal pain and stiffness for at least 2 weeks prior to randomization. This is defined by having a score of \>1 on questions #2 and #5 of the BASDAI score for the 2 weeks prior to randomization.
• Patients receiving NSAIDS and/or COX-2 inhibitors must be on stable doses for at least 2 weeks prior to randomization.
• Age \>18 years
• Male and female patients, who are not surgically sterile or postmenopausal, must use reliable methods of birth control for the duration of the study. Males must agree to use barrier contraception for 3 months following the end of the trial.
• Women of childbearing potential, not surgically sterile or postmenopausal, must have a negative serum beta HCG.

You may not qualify if:

• Use of DMARDs (methotrexate, d-penicillamine, sulfasalazine, azathioprine, hydroxychloroquine, or gold) within 8 weeks of randomization.
• Use of systemic corticosteroids within 4 weeks of randomization
• Use of intravenous or intra-articular corticosteroids within 4 weeks of randomization
• Use of TNF alpha blockers (eg, infliximab, adalimumab) or etanercept as follows:
• Therapy with an investigational agent within 30 days of randomization or 5 half-lives (pharmacokinetic or pharmacodynamic), which ever is longer
• Known HIV or hepatitis B or C infection
• History of active Mycobacterium tuberculosis infection (any subspecies) 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)
• Clinically significant abnormality on chest x-ray (CXR) if mantoux \>5mm or ELISPOT positive
• History of other rheumatic autoimmune diseases (eg, systemic lupus erythematosus, rheumatoid arthritis, etc.)
• Pregnant or nursing women
• Any condition, in the investigator's opinion, which places the patient at an undue risk by participating in the study.
• An estimated glomerular filtration rate (eGFR) of \< 60 ml/min (because of the small risk of nephrogenic sclerosing fibrosis with gadolinium intravenous contrast), if patient is to have MRI with gadolinium contrast .
• Claustrophobia
• Hemoglobin \< 9 g/dL

Sponsors & Collaborators

• Imperial College London: lead
• Celgene Corporation: collaborator

Study Sites (1)

The Kennedy Institute Clinical Trials Unit, 4 West, Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

Related Publications (1)

• Pathan E, Abraham S, Van Rossen E, Withrington R, Keat A, Charles PJ, Paterson E, Chowdhury M, McClinton C, Taylor PC. Efficacy and safety of apremilast, an oral phosphodiesterase 4 inhibitor, in ankylosing spondylitis. Ann Rheum Dis. 2013 Sep 1;72(9):1475-80. doi: 10.1136/annrheumdis-2012-201915. Epub 2012 Sep 14.

  PMID: 22984171 RESULT

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

apremilast; Sugars

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Carbohydrates

Limitations and Caveats

It was most likely underpowered to detect a significant benefit of Apremilast in AS patients because no information on an effect size was available to aid in the study design.

Results Point of Contact

• Title: Peter Taylor
• Organization: Imperial College London

jrco@imperial.ac.uk

+44 (0) 2075941872

Study Officials

• Peter Taylor

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2009
• First Posted: July 23, 2009
• Study Start: August 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: December 6, 2019
• Results First Posted: December 6, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)