Psoriatic ArthritisNCT00963313
A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis
An observational study of Psoriatic Arthritis, run by Dr. FRANCISCO J. BLANCO-GARCIA at 22 sites in Spain.
Trial summary
Based on published data and according to the approved product label for ankylosing spondylitis and psoriatic arthritis, it can be expected that adalimumab 40 mg every 14 days should be effective in psoriatic arthritic patients with axial involvement. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Psoriatic Arthritis
- What is being tested?
- Adalimumab (HUMIRA®)
- Type of treatment
- Injection or infusion
- How many people
- 29 participants
- Where
- 22 sitesSpain
- Study dates
- Mar 2010to Jun 2014
- Phase
- Observational
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with active axial forms of psoriatic arthritis
Who may be able to join
- Males and females aged between 18 and 70 years.
- A negative pregnancy test for women of childbearing potential during the screening period.
- Subject must be evaluated for active or latent TB (tuberculosis) infection by using a PPD skin test (Mantoux test), Booster test, chest x-ray and detailed review of subjetc´s medical history.
- Subjects to whom the doctor has decided to prescribe adalimumab, because of fulfilling the requirements for this treatment.
- Diagnosed with PsA according to CASPAR criteria.
- Axial disease according to radiological criteria (at least unilateral sacroilitis grade II) and spinal inflammatory symptoms.
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- Disease duration of no less than 24 weeks
- Patients with peripheral involvement (mixed forms of APs) must have been taking MTX for at least 12 weeks before screening and at stable doses of 10 to 25 mg/week for 8 weeks before screening, or salazopyrine up to 3 mg/daily, or cyclosporin 2mg/kg or leflunomide 20 mg daily in the same conditions as MTX.
- Patient's doses of NSAIDs and oral corticosteroids (≤ 10 mg/day of prednisone or equivalent) should have been kept stable for 4 weeks before screening.
Who cannot join
- Contraindications for treatment with anti-TNF.
- Prior treatment with other TNF inhibitors or other investigational drugs during the last 30 days (etanercept 4 weeks, infliximab 8 weeks).
- Uncontrolled diabetes.
- Uncontrolled high blood pressure.
- Unstable ischemic heart disease.
- Congestive heart failure.
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- Severe pulmonary disease.
- Chronic leg ulcer.
- History of cancer or malignant lymphoproliferative disease.
- Positive serology for Hepatitis B indicating active infection or positive serology for Hepatitis C.
- History of positive HIV status.
- Persistent, recurrent or severe infections requiring hospitalization or treatment with oral antibiotics within 14 days prior to enrollment.
- Previous diagnosis or signs highly indicative of central nervous system demyelinating diseases.
- Active tuberculosis, histoplasmosis or listeriosis.
- History or presence of confirmed blood dyscrasia.
- Female subjects who are pregnant or breast-feeding.
- History of clinically significant drug or alcohol abuse in the last year.
- Treatment with MTX, salazopyrine, ciclosporin or leflunomide initiated within the last 4 weeks before the screening. Treatment with corticosteroids (>10mg/day or equivalent or modified dose within the previous 4 weeks before screening). And patients where an intraarticular corticoid infiltration has been practised within the last 4 weeks before the screening will be excluded from the study.
- Treatment with more than one NSAID within the last 4 weeks before the screening.
- Patients treated with any DMARD different from MTX, cyclosporine, leflunomide and sulfasalazine.
- Dosage of concomitant MTX, cyclosporine, leflunomide and sulfasalazine must be stable during the study, otherwise it should be properly justified and recorded in the case report form.
- Patients treated with any analgesic different from acetominophen, NSAIDs, oxycodone, codeine, propoxyphene, tramadol, hydrocodone or combinations of these products or equivalents. The use of potent opioids is not permitted.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Spain22 sites
Complejo Hospitalario Universitario A Coruna
A Coruña, A Coruna, 15006
Hospital del Mar
Barcelona, Barcelona, 08003
Hospital Vall d´Hebron
Barcelona, Barcelona, 08035
Hospital Basurto
Bilbao, Bilbao, 48013
Hospital San Pedro de Alcantara
Cáceres, Caceres, 10003
Hospital Universitario Reina Sofia
Córdoba, Cordoba, 14004
Hospital Donostia
Donostia / San Sebastian, San Sebastian, 20014
Hospital de Elche
Elche, Alicante, 03203
Hospital Arquitecto Marcide-Novoa Santos
Ferrol, A Coruna, 15405
Hospital General de Jerez
Jerez de la Frontera, Cadiz, 11407
Hospital Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Hospital Doctor Negrin
Las Palmas, Gran Canaria, 35010
Hospital Insular de Las Palmas
Las Palmas, Gran Canaria, 35016
Hospital Orense
Ourense, Orense, 32005
Hospital Central de Asturias
Oviedo, Principality of Asturias, 33006
Hospital Monte Naranco
Oviedo, Principality of Asturias, 33012
Hospital Pontevedra
Pontevedra, Pontevedra, 36001
Hospital Parc Tauli
Sabadell, Barcelona, 08208
Hospital de Salamanca
Salamanca, Salamanca, 37007
Hospital Virgen de la Macarena
Seville, Sevilla, 41007
Hospital Meixoeiro
Vigo, Pontevedra, 36214
Hospital Comarcal Villajoyosa
Villajoyosa, Alicante, 03570
About this study
Based on published data and according to the approved product label for ankylosing spondylitis and psoriatic arthritis, it can be expected that adalimumab 40 mg every 14 days should be effective in psoriatic arthritic patients with axial involvement.
Read the detailed description
A recent review from GRAPPA group evaluates therapies for PsA including peripheral and axPsA. Analysing particularly the results with present biologic therapies it has been proven that outcome data at 24 weeks show excellent results in the treatment of peripheral forms of PsA with either of the three biologics disposable in the market, that is to say infliximab, etanercept and adalimumab.
However when it comes to analyse data on PsA patients with axPsA there are not results at all. The design of clinical trials did not evaluate axial outcomes and therefore there is not a possibility of knowing whether these therapies are useful in axPsA.
This is an open label multicenter study designed to evaluate the effectivity of adalimumab 40 mg every 2 weeks during 24 weeks in patients with active axial PsA despite receiving Methotrexate, Sulfasalazine, Leflunomide or Cyclosporine, plus NSAIDs and no more than 10 mg of corticosteroids.
- Conditions
- Psoriatic Arthritis
- Being tested
- Adalimumab (HUMIRA®)
- Keywords
- Axial psoriatic arthritis, Adalimumab, Humira, anti-TNF
- Medical subject headings
- Arthritis, Psoriatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab (HUMIRA®)Drug
Also called HUMIRA®
Prefilled syringes containing 40 mg Adalimumab in 0.8 ml injection solution. Study drug will be subcutaneously self-administered every 2 weeks during 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Adalimumab, injection | Adalimumab, one injection every fourteen days during 24 weeks. Receives: Drug: Adalimumab (HUMIRA®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
BASDAI score (Bath Ankylosing Spondylitis Disease Activity Index).
Proportion of patients that reach a BASDAI 50% at week 12, BASDAI 50% means an improvement from baseline of 50% or an improvement of two units on a 10 unit scale.
Measured: 12 WEEKS
Number of participants with new adverse events.
Measured: 24 WEEKS
Secondary outcomes (13)
ASAS 40 score.
Measured: 24 WEEKS
ASAS 50 and ASAS 70 score, 5/6.
Measured: 12 WEEKS
Evaluation of enthesitis.
Measured: 24 WEEKS
Peripheral articulation measured with DAS 28.
Measured: 24 WEEKS
Evaluation of extraarticular manifestations.
Measured: 24 WEEKS
Measure of laboratory parameters.
Hematology, biochemistry, CRP, ESR, HLA-B27 and rheumatoid factor.
Measured: 24 WEEKS
Evaluation of quality of life.
SF36
Measured: 24 WEEKS
Measure of PASI (Psoriasis Area and Severity Index).
Measured: 24 WEEKS
Measure of Modified NAPSI (Modified Nail Psoriasis Severity Index).
Measured: 24 WEEKS
Measure of BASFI (Bath Ankylosing Spondylitis Functioning Index).
Measured: 24 WEEKS
Evaluation of health.
HAQ (Health Assessment Questionarie).
Measured: 24 WEEKS
Evaluation of dactylitis.
Measured: 24 WEEKS
Measure of inflammatory biomarkers (IL6 and MMP3).
Measured: 24 WEEKS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2009 (estimated)
- Study startMar 2010
- Primary completionJun 2012
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriatic 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. FRANCISCO J. BLANCO-GARCIA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. FRANCISCO J. BLANCO-GARCIA, Instituto de Investigacion Biomedica de A Coruna
- Investigators
- Francisco J. Blanco-Garcia, MD, PhD, Study chair, Complejo Hospitalario Universitario A Coruna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00963313
- Sponsor's protocol ID
- SUE-ADA-2009-01
- Status last verified
- Sep 2014
- First submitted
- 20 Aug 2009
- Last updated
- 23 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis
- ClinicalTrials.gov ID
- NCT00963313
- Acronym / sponsor ID
- SUE-ADA-2009-01
- Conditions
- Psoriatic Arthritis
- Keywords
- Axial psoriatic arthritis, Adalimumab, Humira, anti-TNF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Dr. FRANCISCO J. BLANCO-GARCIAUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Aug 2009 (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.
Based on published data and according to the approved product label for ankylosing spondylitis and psoriatic arthritis, it can be expected that adalimumab 40 mg every 14 days should be effective in psoriatic arthritic patients with axial involvement.
Detailed description
A recent review from GRAPPA group evaluates therapies for PsA including peripheral and axPsA. Analysing particularly the results with present biologic therapies it has been proven that outcome data at 24 weeks show excellent results in the treatment of peripheral forms of PsA with either of the three biologics disposable in the market, that is to say infliximab, etanercept and adalimumab.
However when it comes to analyse data on PsA patients with axPsA there are not results at all. The design of clinical trials did not evaluate axial outcomes and therefore there is not a possibility of knowing whether these therapies are useful in axPsA.
This is an open label multicenter study designed to evaluate the effectivity of adalimumab 40 mg every 2 weeks during 24 weeks in patients with active axial PsA despite receiving Methotrexate, Sulfasalazine, Leflunomide or Cyclosporine, plus NSAIDs and no more than 10 mg of corticosteroids.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adalimumab, injection | – | Drug: Adalimumab (HUMIRA®)Adalimumab, one injection every fourteen days during 24 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with active axial forms of psoriatic arthritis
Key inclusion criteria (9 listed)
- Males and females aged between 18 and 70 years.
- A negative pregnancy test for women of childbearing potential during the screening period.
- Subject must be evaluated for active or latent TB (tuberculosis) infection by using a PPD skin test (Mantoux test), Booster test, chest x-ray and detailed review of subjetc´s medical history.
- Subjects to whom the doctor has decided to prescribe adalimumab, because of fulfilling the requirements for this treatment.
- Diagnosed with PsA according to CASPAR criteria.
Key exclusion criteria (22 listed)
- Contraindications for treatment with anti-TNF.
- Prior treatment with other TNF inhibitors or other investigational drugs during the last 30 days (etanercept 4 weeks, infliximab 8 weeks).
- Uncontrolled diabetes.
- Uncontrolled high blood pressure.
- Unstable ischemic heart disease.
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 |
|---|---|---|
| Adalimumab (HUMIRA®)Also: HUMIRA®Prefilled syringes containing 40 mg Adalimumab in 0.8 ml injection solution. Study drug will be subcutaneously self-administered every 2 weeks during 24 weeks. | Drug | Adalimumab, injection |
Primary outcome
BASDAI score (Bath Ankylosing Spondylitis Disease Activity Index).
Time frame: 12 WEEKS
Proportion of patients that reach a BASDAI 50% at week 12, BASDAI 50% means an improvement from baseline of 50% or an improvement of two units on a 10 unit scale.
Number of participants with new adverse events.
Time frame: 24 WEEKS
13 secondary outcomes
ASAS 40 score.
Time frame: 24 WEEKS
ASAS 50 and ASAS 70 score, 5/6.
Time frame: 12 WEEKS
Evaluation of enthesitis.
Time frame: 24 WEEKS
Peripheral articulation measured with DAS 28.
Time frame: 24 WEEKS
Evaluation of extraarticular manifestations.
Time frame: 24 WEEKS
Measure of laboratory parameters.
Time frame: 24 WEEKS
Evaluation of quality of life.
Time frame: 24 WEEKS
Measure of PASI (Psoriasis Area and Severity Index).
Time frame: 24 WEEKS
Measure of Modified NAPSI (Modified Nail Psoriasis Severity Index).
Time frame: 24 WEEKS
Measure of BASFI (Bath Ankylosing Spondylitis Functioning Index).
Time frame: 24 WEEKS
Evaluation of health.
Time frame: 24 WEEKS
Evaluation of dactylitis.
Time frame: 24 WEEKS
Measure of inflammatory biomarkers (IL6 and MMP3).
Time frame: 24 WEEKS
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 23 Sep 2014.
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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.
Francisco J. Blanco-Garcia, MD, PhD study chair
Complejo Hospitalario Universitario A Coruna
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Psoriatic Arthritis, run by Dr. FRANCISCO J. BLANCO-GARCIA at 22 sites in Spain.
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 9 inclusion and 22 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 23 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain. 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.
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?
BASDAI score (Bath Ankylosing Spondylitis Disease Activity Index). (time frame: 12 WEEKS). The study lists 2 primary outcomes in all. 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 23 Sep 2014.