Remicade Study in Psoriatic Arthritis Patients Of Methotrexate-Naïve Disease (RESPOND) (Study P04422)

NCT00367237 | Completed Phase 3 Results

• 2 other identifiers: P04422EUDRACT #: 2005-002189-12
• Study Type: interventional
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is undertaken to compare the efficacy and onset of action of infliximab plus methotrexate (IFX + MTX) versus methotrexate alone (MTX) in methotrexate naïve active psoriatic arthritis patients.

Conditions

Arthritis, Psoriatic

Outcome Measures

Primary Outcomes (1)

• Number of Subjects Achieving ACR20 (at Least 20% Improvement in American College of Rheumatology Criteria From Baseline) at Week 16

  \>=20% improvement in swollen and tender joint count AND \>=20% improvement in 3 of the following: visual analog scale (VAS) assessment of pain; subject VAS global assessment of disease activity; evaluator VAS global assessment of disease activity; Health Assessment Questionnaire (HAQ) disability index; C-Reactive Protein (CRP) level.

  between baseline and week 16

Secondary Outcomes (3)

• Proportion of Subjects Achieving ACR50, ACR70, and PASI75 if Applicable

  between baseline and week 16

• Change in Disease Activity Score, Each of the ACR20 Domains, Dactylitis, Enthesitis, Fatigue and Duration of Morning Stiffness, Erythrocyte Sedimentation Rate, and Disability Index of the Health Assessment Questionnaire (HAQ)

  between baseline and week 16

• Adverse Events

  between baseline and week 16

Study Arms (2)

Infliximab + methotrexate (IFX + MTX)

EXPERIMENTAL

Remicade (infliximab \[IFX\]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week

Drug: Infliximab + methotrexate (IFX + MTX)

Methotrexate (MTX)

ACTIVE COMPARATOR

Oral methotrexate (MTX) 15 mg/week

Drug: Methotrexate (MTX)

Interventions

Infliximab + methotrexate (IFX + MTX) DRUG

Infliximab 5 mg/kg infusion at Weeks 0, 2, 6, 14 and oral methotrexate 15 mg/week for 16 weeks. Methotrexate dose can be increased to 20 mg/week at week 6.

Also known as: Group 1, Remicade + MTX

Infliximab + methotrexate (IFX + MTX)

Methotrexate (MTX) DRUG

Oral methotrexate 15 mg/week for 15 weeks. Dose can be increased to 20 mg/week at Week 6.

Also known as: Group 2, MTX

Methotrexate (MTX)

Eligibility Criteria

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

You may qualify if:

• The subject must meet ALL of the criteria listed below for entry into the study:
• Subject must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
• Subject aged 18 years or more, of either sex and any race
• Diagnosis of Psoriatic Arthritis with peripheral polyarticular involvement. Patients will have at least one of the following:
• Distal Interphalangeal Joints (DIP) involvement
• polyarticular arthritis, absence of rheumatoid nodules and presence of psoriasis
• arthritis mutilans
• asymmetric peripheral arthritis
• Negative rheumatoid factor
• The disease should have been diagnosed at least 3 months prior to screening.
• Active disease at the time of screening and prior to receiving the baseline study medication(s) as defined by:
• or more swollen joints and
• or more tender joints
• and one out of the following three categories:
• Erythrocyte Sedimentation Rate (ESR) \>= 28 mm/h

You may not qualify if:

• The subject will be excluded from entry into the study if ANY of the criteria listed below are met:
• Subject is a female who is pregnant, intends to become pregnant during the study (or within 6 months after study completion), or nursing.
• Patients with other inflammatory diseases that might interfere with the evaluation of the psoriatic arthritis.
• Previous treatment with Infliximab.
• Subjects who have previously received MTX or have not discontinued their other DMARD therapy (i.e., sulfasalazine, hydroxychloroquine, leflunomide).
• Patients with fibromyalgia syndrome.
• Use of cyclosporine or tacrolimus within 4 weeks prior to screening. Use of IM, IV, or IA corticosteroids within 4 weeks prior to screening.
• Treatment with any investigational drug within 3 months prior to screening.
• Previous treatment with a monoclonal antibody or a fusion protein.
• A history of known allergy to murine proteins.
• History of infected joint prosthesis within the previous 5 years.
• Chronic infections.
• History of active tuberculosis requiring treatment within previous 3 years or history of opportunistic infections within 2 months, uncontrolled active infection or documented HIV infection. Also excluded are patients with evidence of latent tuberculosis and patients with old tuberculosis without documented adequate therapy, if they will not be treated according to local tuberculosis (TB) guidelines.
• Subject has any clinically significant deviation from normal in the physical examination, chest X-ray, or electrocardiogram (ECG) that, in the investigator's judgment, may interfere with the study evaluation or affect subject safety.
• Current signs or symptoms of other severe uncontrolled diseases, which in the investigators opinion would put the patient at an unacceptable risk.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Integrated Therapeutics Group: collaborator

Related Publications (1)

• Baranauskaite A, Raffayova H, Kungurov NV, Kubanova A, Venalis A, Helmle L, Srinivasan S, Nasonov E, Vastesaeger N; RESPOND investigators. Infliximab plus methotrexate is superior to methotrexate alone in the treatment of psoriatic arthritis in methotrexate-naive patients: the RESPOND study. Ann Rheum Dis. 2012 Apr;71(4):541-8. doi: 10.1136/ard.2011.152223. Epub 2011 Oct 12.

  PMID: 21994233 DERIVED

MeSH Terms

Conditions

Arthritis, Psoriatic

Interventions

Infliximab; Methotrexate

Condition Hierarchy (Ancestors)

Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Psoriasis; Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp.

ClinicalTrialsDisclosure@merck.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2006
• First Posted: August 22, 2006
• Study Start: May 1, 2006
• Primary Completion: March 1, 2008
• Study Completion: March 1, 2008
• Last Updated: April 11, 2017
• Results First Posted: July 7, 2009

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will share