Study of Adalimumab in Participants With Peripheral Spondyloarthritis (SpA)

NCT01064856 | Completed Phase 3 Results

• 2 other identifiers: M10-8832009-014567-39
• Study Type: interventional
• Target: 165
• Locations: 0 countries
• Sites: N/A

Brief Summary

The objective of this study was to evaluate the efficacy and safety of adalimumab 40 mg administered every other week (eow) subcutaneously (SC) compared to placebo for 12 weeks followed by open label (OL) safety and efficacy assessments in participants with non-ankylosing spondylitis (AS), non-psoriatic arthritis (PsA) active peripheral spondyloarthritis (SpA) who have had an inadequate response to \>= 2 non-steroidal anti-inflammatory drugs (NSAIDs), or are intolerant to, or have a contraindication for, NSAIDs.

Conditions

Peripheral Spondyloarthritis

Keywords

peripheral spondyloarthritis; adalimumab; humira

Outcome Measures

Primary Outcomes (2)

• Percentage of Responders According to the Composite Peripheral SpA Response Criteria (PSpARC 40) at Week 12

  Percentage of participants achieving the following composite response at Week 12: \>= 40% improvement (minimum 20 mm absolute improvement) from Baseline in Patient Global Assessment (PTGA) of Disease Activity as measured by a 100 mm visual analogue scale (VAS) where 0=no symptoms and 100=maximum symptoms; \>= 40% improvement (minimum 20 mm absolute improvement) from Baseline in PTGA - Pain as measured by a 100 mm VAS where 0=no pain and 100=maximum pain; and \>= 40% improvement from Baseline in at least 1 of the following 3 criteria: swollen joint count (76 joints) and tender joint count (78 joints); total enthesitis count; or total dactylitis count. Non-responder imputation: missing response was imputed as non-response.

  Week 12

• Number of Participants With Adverse Events

  An adverse event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with treatment. If an adverse event meets any of the following criteria, it is considered a serious adverse event (SAE): results in death or is life-threatening, results in admission or prolongation of hospitalization, results in congenital anomaly or persistent or significant disability/incapacity, or is an important medical event requiring medical or surgical intervention to prevent serious outcome. AEs were categorized by severity (mild, moderate, severe) and relationship to treatment (probably, possibly, probably not, not related). Please see Adverse Events section below for more details.

  Baseline (day of first study drug administration) through Week 156 plus 70 days

Secondary Outcomes (11)

• Change From Baseline in Physician Global Assessment (PGA) of Disease Activity at Week 12

  Baseline (last measurement prior to first DB dose), Week 12

• Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12

  Baseline (last measurement prior to first DB dose), Week 12

• Change From Baseline in Health Assessment Questionnaire Modified for the Spondyloarthropathies (HAQ-S) Total at Week 12

  Baseline (last measurement prior to first DB dose), Week 12

• Change From Baseline in Short Form-36 Health Status Survey™ Version 2 (SF-36™V2) Physical Component Score (PCS) at Week 12

  Baseline (last measurement prior to first DB dose), Week 12

• Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12

  Baseline (last measurement prior to first DB dose), Week 12

Study Arms (4)

Double-blind (DB) Adalimumab

EXPERIMENTAL

Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.

Biological: Adalimumab

Double-blind Placebo

PLACEBO COMPARATOR

Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.

Biological: Placebo

Double-blind Adalimumab / Open-label Adalimumab

EXPERIMENTAL

Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.

Biological: Adalimumab

Double-blind Placebo / Open-label Adalimumab

PLACEBO COMPARATOR

Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.

Biological: Adalimumab; Biological: Placebo

Interventions

Adalimumab BIOLOGICAL

Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing adalimumab 40 mg/0.8 mL. Study drug was SC self-administered eow at approximately the same time of day.

Also known as: ABT-D2E7, Humira

Double-blind (DB) Adalimumab; Double-blind Adalimumab / Open-label Adalimumab; Double-blind Placebo / Open-label Adalimumab

Placebo BIOLOGICAL

Study drug was provided as a sterile SC injection solution in 1 mL pre-filled syringes containing matching placebo for adalimumab. Study drug was SC self-administered eow at approximately the same time of day.

Double-blind Placebo; Double-blind Placebo / Open-label Adalimumab

Eligibility Criteria

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

You may qualify if:

• Adult participants who had inadequate response to \>= 2 non-steroidal anti-inflammatories (NSAIDs)
• Participants who had arthritis or enthesitis or dactylitis plus: met spondyloarthritis clinical criteria
• Negative purified protein derivative (PPD) test and Chest X-Ray performed at Baseline Visit were Negative
• Ability to administer subcutaneous injections
• General good health

You may not qualify if:

• Prior anti-tumor necrosis factor (TNF) therapy
• Psoriasis or Psoriatic Arthritis
• Fulfillment of modified New York criteria for Ankylosing Spondylitis
• Recent infection requiring treatment
• Significant medical events or conditions that had put patients at risk for participation
• Female participants who were pregnant or breast-feeding or considering becoming pregnant during the study
• History of cancer, except successfully treated skin cancer
• Recent history of drug or alcohol abuse

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Publications (4)

• Mease P, Sieper J, Van den Bosch F, Rahman P, Karunaratne PM, Pangan AL. Randomized controlled trial of adalimumab in patients with nonpsoriatic peripheral spondyloarthritis. Arthritis Rheumatol. 2015 Apr;67(4):914-23. doi: 10.1002/art.39008.

  PMID: 25545240 BACKGROUND

• Coates LC, Abraham S, Tillett W, Mease PJ, Ramiro S, Wu T, Wang X, Pangan AL, Song IH. Performance and Predictors of Minimal Disease Activity Response in Patients With Peripheral Spondyloarthritis Treated With Adalimumab. Arthritis Care Res (Hoboken). 2022 Feb;74(2):259-267. doi: 10.1002/acr.24442. Epub 2021 Dec 29.

  PMID: 32937016 DERIVED

• Mease PJ, Van den Bosch F, Sieper J, Xia Y, Pangan AL, Song IH. Performance of 3 Enthesitis Indices in Patients with Peripheral Spondyloarthritis During Treatment with Adalimumab. J Rheumatol. 2017 May;44(5):599-608. doi: 10.3899/jrheum.160387. Epub 2017 Mar 15.

  PMID: 28298558 DERIVED

• Turina MC, Ramiro S, Baeten DL, Mease P, Paramarta JE, Song IH, Pangan AL, Landewe R. A psychometric analysis of outcome measures in peripheral spondyloarthritis. Ann Rheum Dis. 2016 Jul;75(7):1302-7. doi: 10.1136/annrheumdis-2014-207235. Epub 2015 Aug 5.

  PMID: 26245756 DERIVED

Related Links

• This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.

MeSH Terms

Interventions

Adalimumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie

800-633-9110

Study Officials

• In-Ho Song, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2010
• First Posted: February 9, 2010
• Study Start: February 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: May 1, 2014
• Last Updated: July 7, 2021
• Results First Posted: November 25, 2016

Record last verified: 2021-07