A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis

• ClinicalTrials.gov Identifier: NCT00963313
• Recruitment Status: Completed
• First Posted: August 21, 2009
• Last Update Posted: September 23, 2014
• Sponsor: Dr. FRANCISCO J. BLANCO-GARCIA
• Information provided by (Responsible Party): Dr. FRANCISCO J. BLANCO-GARCIA, Instituto de Investigacion Biomedica de A Coruna

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Psoriatic Arthritis	Drug: Adalimumab (HUMIRA®)

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

• Study Type: Observational
• Actual Enrollment: 29 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A 24 Week Open Label Study of the Utility of Adalimumab in Active Axial Forms of Psoriatic Arthritis
• Study Start Date: March 2010
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: June 2014

Groups and Cohorts

Group/Cohort	Intervention/treatment
Adalimumab, injection; Adalimumab, one injection every fourteen days during 24 weeks.	Drug: Adalimumab (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.; Other Name: HUMIRA®

Outcome Measures

Primary Outcome Measures :

1. 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.
2. Number of participants with new adverse events. [ Time Frame: 24 WEEKS ]

Secondary Outcome Measures :

1. ASAS 40 score. [ Time Frame: 24 WEEKS ]
2. ASAS 50 and ASAS 70 score, 5/6. [ Time Frame: 12 WEEKS ]
3. Evaluation of enthesitis. [ Time Frame: 24 WEEKS ]
4. Peripheral articulation measured with DAS 28. [ Time Frame: 24 WEEKS ]
5. Evaluation of extraarticular manifestations. [ Time Frame: 24 WEEKS ]
6. Measure of laboratory parameters. [ Time Frame: 24 WEEKS ]
   Hematology, biochemistry, CRP, ESR, HLA-B27 and rheumatoid factor.
7. Evaluation of quality of life. [ Time Frame: 24 WEEKS ]
   SF36
8. Measure of PASI (Psoriasis Area and Severity Index). [ Time Frame: 24 WEEKS ]
9. Measure of Modified NAPSI (Modified Nail Psoriasis Severity Index). [ Time Frame: 24 WEEKS ]
10. Measure of BASFI (Bath Ankylosing Spondylitis Functioning Index). [ Time Frame: 24 WEEKS ]
11. Evaluation of health. [ Time Frame: 24 WEEKS ]
    HAQ (Health Assessment Questionarie).
12. Evaluation of dactylitis. [ Time Frame: 24 WEEKS ]
13. Measure of inflammatory biomarkers (IL6 and MMP3). [ Time Frame: 24 WEEKS ]

Biospecimen Retention:   Samples Without DNA

Samples recollected for analysing IL6 and MMP3 from patients blood serum.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients with active axial forms of psoriatic arthritis

Criteria

Inclusion Criteria:

• 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.
• 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.

Exclusion Criteria:

• 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.
• 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.

Contacts and Locations

Locations

Spain

Hospital Arquitecto Marcide-Novoa Santos

Ferrol, A Coruna, Spain, 15405

Hospital de Elche

Elche, Alicante, Spain, 03203

Hospital Comarcal Villajoyosa

Villajoyosa, Alicante, Spain, 03570

Hospital Central de Asturias

Oviedo, Asturias, Spain, 33006

Hospital Monte Naranco

Oviedo, Asturias, Spain, 33012

Hospital Bellvitge

L´Hospitalet de Llobregat, Barcelona, Spain, 08907

Hospital Parc Tauli

Sabadell, Barcelona, Spain, 08208

Hospital General de Jerez

Jerez de la Frontera, Cadiz, Spain, 11407

Hospital Doctor Negrin

Las Palmas, Gran Canaria, Spain, 35010

Hospital Insular de Las Palmas

Las Palmas, Gran Canaria, Spain, 35016

Hospital Meixoeiro

Vigo, Pontevedra, Spain, 36214

Complejo Hospitalario Universitario A Coruna

A Coruna, Spain, 15006

Hospital del Mar

Barcelona, Spain, 08003

Hospital Vall d´Hebron

Barcelona, Spain, 08035

Hospital Basurto

Bilbao, Spain, 48013

Hospital San Pedro de Alcantara

Caceres, Spain, 10003

Hospital Universitario Reina Sofia

Cordoba, Spain, 14004

Hospital Orense

Orense, Spain, 32005

Hospital Pontevedra

Pontevedra, Spain, 36001

Hospital de Salamanca

Salamanca, Spain, 37007

Hospital Donostia

San Sebastian, Spain, 20014

Hospital Virgen de la Macarena

Sevilla, Spain, 41007

Sponsors and Collaborators

Dr. FRANCISCO J. BLANCO-GARCIA

Investigators

• Study Chair: Francisco J. Blanco-Garcia, MD, PhD; Complejo Hospitalario Universitario A Coruna

More Information

• Responsible Party: Dr. FRANCISCO J. BLANCO-GARCIA, MD, PhD, Instituto de Investigacion Biomedica de A Coruna
• ClinicalTrials.gov Identifier: NCT00963313
• Other Study ID Numbers: SUE-ADA-2009-01
• First Posted: August 21, 2009
• Last Update Posted: September 23, 2014
• Last Verified: September 2014

Keywords provided by Dr. FRANCISCO J. BLANCO-GARCIA, Instituto de Investigacion Biomedica de A Coruna:

Axial psoriatic arthritis; Adalimumab; Humira; anti-TNF

Additional relevant MeSH terms:

Arthritis; Arthritis, Psoriatic; Joint Diseases; Musculoskeletal Diseases; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Adalimumab; Anti-Inflammatory Agents; Antirheumatic Agents