NSAIDs Added to Anti-TNF Therapy Versus Anti-TNF Therapy Alone on Progression of Structural Damage in Ankylosing Spondylitis

NCT02758782 | Completed Phase 4 DMC

• 1 other identifier: CONSUL2016
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 19

Brief Summary

To evaluate the impact of treatment with a non-steroidal anti-inflammatory drug (NSAID) - Celecoxib - when added to anti-tumour necrosis factor (TNF) therapy - Golimumab - as compared to anti-TNF therapy (Golimumab) alone on progression of structural damage in the spine over two years in patients with ankylosing spondylitis (AS).

Conditions

Ankylosing Spondylitis

Outcome Measures

Primary Outcomes (1)

• Absolute progression of the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) over two years of therapy (weeks 12-108) in the Phase II (core phase) of the trial

  Absolute progression of the modified Stoke Ankylosing Spondylitis Spine Score (mSASSS) over two years of therapy (weeks 12-108) in the Phase II (core phase) of the trial

  2 years

Secondary Outcomes (9)

• New syndesmophyte formation or progression of existing syndesmophytes

  2 years

• Improvement of disease activity (BASDAI)

  2 years

• Improvement of disease activity (ASDAS)

  2 years

• Improvement of function (BASFI)

  2 years

• Improvement of axial mobility (BASMI)

  2 years

Study Arms (2)

Golimumab monotherapy

ACTIVE COMPARATOR

Treatment with 50 mg Golimumab subcutaneous once monthly

Biological: Golimumab

Golimumab combined with Celecoxib

ACTIVE COMPARATOR

Treatment with Golimumab 50 mg subcutaneous once monthly in combination with Celecoxib 400 mg orally every day

Biological: Golimumab; Drug: Celecoxib

Interventions

Golimumab BIOLOGICAL

Also known as: Simponi

Golimumab combined with Celecoxib; Golimumab monotherapy

Celecoxib DRUG

Also known as: Celebrex

Golimumab combined with Celecoxib

Eligibility Criteria

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

You may qualify if:

• Definite diagnosis of AS according to the "modified New York criteria".
• History of an inadequate response to ≥2 NSAIDs taken for at least 2 weeks each.
• Active disease as defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) value of ≥4 at screening.
• Presence of at least one of the following risk factors for radiographic spinal progression:
• Elevated C reactive protein (CRP; \>5mg/l) at screening at the absence of reasons for elevated CRP other than AS;
• Presence of ≥ 1 syndesmophyte on prior X-rays of the spine.
• Subject is a candidate for anti-TNF therapy based on the Investigator's opinion.
• Subject is able and willing to give a written informed consent and comply with the requirements of the study protocol. Only patients who give written informed consent will be included in the trial.
• If female: either unable to bear children (postmenopausal for at least 1 year or surgically sterile) or is willing and able to practice a reliable method of contraception throughout the study and 6 months after
• \- adequate response to Golimumab during Phase I (referred to as decline in BASDAI)

You may not qualify if:

• For female subjects: pregnancy or lactating
• subjects with chronic inflammatory articular disease other than spondyloarthritis / AS or systemic autoimmune disease, e.g. systemic lupus erythematosus, Sjögren´s syndrome, rheumatoid arthritis.
• history of inadequate response to anti-TNF-therapy
• intolerability/hypersensitivity to one of the drugs or other components of the study medication
• presence ot total spinal ankylosis
• contraindications to anti-TNF-therapy (current or remitting clinical significant infections, tuberculosis, viral hepatitis, HIV; malignancies; demyelinating disease; vaccination with live vaccine within 3 months before, during and until 6 months after study)
• (relative) contraindications to Celecoxib therapy (uncontrolled arterial hypertension, high cardiovascular risk / history of cardiovascular events; history of gastrointestinal ulcers or relevant bleeding; known M. Crohn or ulcerative colitis)
• diagnosis of fibromyalgia
• significant lab abnormalities

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (19)

Rheumapraxis Kupka

Altenburg, 04600, Germany

Location

Rheumapraxis Bayreuth Dr. Ochs

Bayreuth, 95444, Germany

Location

Charite Universitaetsmedizin - Dpt. Rheumatology at Campus Charite Mitte

Berlin, 10117, Germany

Location

Rheumatologische Schwerpunktpraxis

Berlin, 12161, Germany

Location

Rheumatologische Praxis Dr. Karberg/Brandt

Berlin, 12163, Germany

Location

Charite Universitaetsmedizin, Dpt. of Rheumatology at Campus Benjamin Franklin

Berlin, 12200, Germany

Location

MVZ Drs. Mielke

Berlin, 12627, Germany

Location

Rheumapraxis Dr. Zinke

Berlin, 13055, Germany

Location

Schlossparkklinik, Dpt. of Rheumatologie

Berlin, 14059, Germany

Location

Rheumatologische Schwerpunktpraxis an den Kreiskliniken

Burghausen, 84489, Germany

Location

Universitätsklinikum Köln, Rheumatologie

Cologne, 50937, Germany

Location

Centrum für innovative Diagnostik und Therapie Rheumatologie/Immunologie (CIRI)

Frankfurt am Main, 60528, Germany

Location

Praxis Dr Kühne

Haldensleben I, 39340, Germany

Location

Medizinische Hochschule, Rheumatologie

Hanover, 30625, Germany

Location

Rheumazentrum Ruhrgebiet

Herne, 44649, Germany

Location

Rheumapraxis Magdeburg

Magdeburg, 39104, Germany

Location

Klinikum Rechts der ISAR (TU München)

München, 81675, Germany

Location

Rheumapraxis Dr. Jacki

Tübingen, 72072, Germany

Location

University of Tuebingen, Dpt. Rheumatology

Tübingen, 72076, Germany

Location

Related Publications (1)

• Proft F, Muche B, Listing J, Rios-Rodriguez V, Sieper J, Poddubnyy D. Study protocol: COmparison of the effect of treatment with Nonsteroidal anti-inflammatory drugs added to anti-tumour necrosis factor a therapy versus anti-tumour necrosis factor a therapy alone on progression of StrUctural damage in the spine over two years in patients with ankyLosing spondylitis (CONSUL) - an open-label randomized controlled multicenter trial. BMJ Open. 2017 Jun 10;7(6):e014591. doi: 10.1136/bmjopen-2016-014591.

  PMID: 28601821 RESULT

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

golimumab; Celecoxib

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Denis Poddubnyy, Prof. Dr.

  Head of Dpt. for Rheumatology at Charite, Campus Benjamin Franklin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr Denis Poddubnyy

Study Record Dates

• First Submitted: April 20, 2016
• First Posted: May 2, 2016
• Study Start: September 1, 2016
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: January 27, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (19)